FDA Device Explorer

Gastroenterology, Urology (GU) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Gastroenterology, Urology (GU) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 876

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
QIJEndoscopic Transhepatic Venous Access Needle876.105021
FCFInstrument, Biopsy, Mechanical, Gastrointestinal876.107526
FCGBiopsy Needle876.10752133
FCIPunch, Biopsy876.107525
FCKInstrument, Biopsy, Suction876.1075213
FCLForceps, Biopsy, Non-Electric876.1075139
FFFCover, Biopsy Forceps876.107511
KNWInstrument, Biopsy876.10752360
NLSInstrument, Biopsy, Reprocessed876.107520
NMXNeedle And Needle Set, Gastro-Urology, Reprocessed876.107520
NONForceps, Biopsy, Non-Electric, Reprocessed876.107513
POZBiopsy Needle Kit876.107520
PRVGastro-Urology Biopsy Kit876.107520
QHCInstrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs876.107520
QFZGastroenterology-Urology Accessories To A Biopsy Instrument876.108010
NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule876.1300246
NSISystem, Imaging, Esophageal, Wireless, Capsule876.130027
QUNTether Accessory For Use In The Gastrointestinal Tract876.130520
QKZMagnetically Maneuvered Capsule Endoscopy System876.131026
PGDColon Capsule Imaging System876.133022
QUDBlood Detection Capsule876.139021
FFTElectrode, Ph, Stomach876.1400149
QISEsophageal, Mucosal, Electrical Characterization876.145023
EXZEquipment, Photographic, For Physiologic Function Monitor876.150010
FAJCystoscope And Accessories, Flexible/Rigid876.1500290
FAKPanendoscope (Gastroduodenoscope)876.150022
FALPanendoscope (Urethroscope)876.150021
FAMSigmoidoscope And Accessories, Flexible/Rigid876.1500224
FANSigmoidoscope, Rigid, Electrical876.150022
FBIRongeur, Cystoscopic876.150020
FBKEndoscopic Injection Needle, Gastroenterology-Urology876.1500288
FBNCholedochoscope And Accessories, Flexible/Rigid876.1500243
FBOCystourethroscope876.1500219
FBPTelescope, Rigid, Endoscopic876.150025
FCCEndoscopic Magnetic Retriever876.150023
FCOBox, Battery, Rechargeable876.1500120
FCPBox, Battery, Pocket876.150012
FCQLight Source, Incandescent, Diagnostic876.150021
FCRLight Source, Photographic, Fiberoptic876.150023
FCWLight Source, Fiberoptic, Routine876.1500231
FCXInsufflator, Automatic Carbon-Dioxide For Endoscope876.1500224
FCYBulb, Inflation, For Endoscope876.150013
FCZTube, Smoke Removal, Endoscopic876.150010
FDAEnteroscope And Accessories876.1500219
FDCResectoscope, Working Element876.1500211
FDELaparoscopy Kit876.150024
FDFColonoscope And Accessories, Flexible/Rigid876.15002111
FDPApparatus, Pneumoperitoneum, Automatic876.150021
FDRSphyncteroscope876.150020
FDSGastroscope And Accessories, Flexible/Rigid876.1500274
FDTDuodenoscope And Accessories, Flexible/Rigid876.1500235
FDWEsophagoscope, Rigid, Gastro-Urology876.150020
FDXEndoscopic Cytology Brush876.1500244
FDYDevice, Measuring, For Panendoscope876.150010
FDZAttachment, Eyepiece, For Insertion Of Prescription Lens876.150012
FEAAttachment, Teaching, For Endoscope876.150012
FEBAccessories, Cleaning, For Endoscope876.1500257
FECObturator, For Endoscope876.150023
FEDEndoscopic Access Overtube, Gastroenterology-Urology876.15002101
FEIInstrument, Special Lens, For Endoscope876.150012
FEJAttachment, Binocular, For Endoscope876.150011
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)876.150014
FEQPump, Air, Non-Manual, For Endoscope876.1500221
FERAnoscope And Accessories876.1500227
FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology876.1500298
FFSImage, Illumination, Fiberoptic, For Endoscope 876.1500226
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope876.150012
FFZCord, Electric, For Endoscope876.150023
FGAKit, Nephroscope876.1500210
FGBUreteroscope And Accessories, Flexible/Rigid876.15002113
FGCUrethroscope876.150023
FGSCarrier, Sponge, Endoscopic876.150024
FHOPneumoperitoneum Needle876.1500215
FHPNeedle, Pneumoperitoneum, Simple876.150022
FHXJelly, Lubricating, For Transurethral Surgical Instrument876.150026
FJLResectoscope876.1500224
FTILamp, Endoscope, Incandescent876.150022
FTJColonoscope, General & Plastic Surgery876.150020
GCFProctoscope876.150022
GCGPeritoneoscope876.150020
GCHMediastinoscope, Diagnostic876.150020
GCILaryngoscope, Endoscope876.1500214
GCJLaparoscope, General & Plastic Surgery876.150021414
GCKGastroscope, General & Plastic Surgery876.150020
GCLEsophagoscope, General & Plastic Surgery876.150024
GCMEndoscope, Rigid876.1500218
GCNEndoscope, Prism876.150020
GCOEndoscope, Mirror876.150023
GCPEndoscope, Ac-Powered And Accessories876.1500213
GCQEndoscope, Flexible876.150025
GCSEndoscope, Battery-Powered And Accessories876.150029
GCTLight Source, Endoscope, Xenon Arc876.1500247
GCWTransformer, Endoscope876.150021
GDBEndoscope, Fiber Optic876.150027
KDMSigmoidoscope, Rigid, Non-Electrical876.150021
KDORongeur, Cystoscopic, Hot876.150021
KGDScissors For Cystoscope876.150022
KYHEndoscope, Ophthalmic876.150021
LYKAngioscope876.1500241
MFJDevice, Endoscopic Suturing876.150021
MNKEndoscopic Bite Block876.150016
MNLAccessories, Cleaning Brushes, For Endoscope876.150014
MPAEndoilluminator876.1500240
NAYSystem, Surgical, Computer Controlled Instrument876.15002162
NBGMarker, Colon876.150022
NEQDevice, Telemedicine, Robotic876.150022
NKZEndoilluminator, Reprocessed876.150020
NLMLaparoscope, General & Plastic Surgery, Reprocessed876.1500223
NLXNeedle, Pneumoperitoneum, Spring Loaded, Reprocessed876.150020
NMYNeedle, Endoscopic, Reprocessed876.150020
NTNLed Light Source876.150029
NVEWasher, Cleaner, Automated, Endoscope876.1500212
NWBEndoscope, Accessories, Narrow Band Spectrum876.150029
NWSKit, Choledochoscope, Flexible And Rigid876.150021
NWTEndoscopic Cholangiogram Kit876.150020
NWUEndoscope Introducer Kit876.150023
NZAAccessories, Germicide, Cleaning, For Endoscopes876.1500211
OCSEndoscopic Video Imaging System/Component, Gastroenterology-Urology876.150021
OCTAnti Fog Solution And Accessories, Endoscopy876.1500227
OCUEndoscopic Storage Cover876.150026
OCVEndoscope Holder876.1500210
OCWEndoscopic Tissue Approximation Device876.1500270
OCXEndoscopic Irrigation/Suction System876.1500293
OCYEndoscopic Guidewire, Gastroenterology-Urology876.1500243
OCZEndoscopic Grasping/Cutting Instrument, Non-Powered876.1500273
ODAEndoscopic Central Control Unit876.1500218
ODBEndoscopic Contamination Prevention Sheath876.150025
ODCEndoscope Channel Accessory876.1500271
ODDEndoscopic Retrograde Cholangiopancreatography (Ercp) Cannula876.1500218
ODEEndoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)876.1500220
ODFMini Endoscope, Gastroenterology-Urology876.1500212
ODGEndoscopic Ultrasound System, Gastroenterology-Urology876.1500242
OTJLaparoscopic Single Port Access Device876.1500211
OWNConfocal Optical Imaging876.1500260
PCVEndoscopic Leak Tester876.150022
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement876.150029
PGUSpatial Imaging For Display Of Endoscope Position876.150021
PHTBasin For Endoscope Reprocessing876.150010
PLLSubmucosal Injection Agent876.150029
PPENephroscope Set876.150020
PTQEndoscopic Magnetic Retriever, Exempt876.150020
PTRScissors For Cytoscope, Exempt876.150020
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt876.150020
PUPEndoscope Maintenance System876.150021
QGYMobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera876.150021
QSMSystem, Surgical, Computer Controlled Instrument, Remanufactured876.150028
QZBSoftware Controlled Endoscope And Instrument Holder876.150023
SBXSoftware For Endoscopy Procedure Metrics876.150020
SFEEndoscopic Video Imaging System / Software Component For Real Time Video Augmentation876.150021
QGGEsophageal Sheath With Distal Balloon Anchor876.151021
QNPGastrointesinal Lesion Software Detection System876.1520219
QTHEndoscopic Light-Projecting Measuring Device876.153021
QZFGastrointestinal Capsule Endoscopy Analysis Software Device876.154022
SCBDeflation Needle For Removal Of Intragastric Balloon876.155020
EXQCystometer, Electrical Recording876.162028
FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device876.1620285
FENDevice, Cystometric, Hydraulic876.1620236
EXWPill, Radio876.172521
FESRecorder, External, Pressure, Amplifier & Transducer876.172522
FFXSystem, Gastrointestinal Motility (Electrical)876.1725269
KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube876.1725231
NYVGastrointestinal Motility System, Capsule876.172524
MYESystem, Electrogastrography (Egg)876.173528
EXRUrinometer, Mechanical876.180029
EXSUrinometer, Electrical876.180020
EXYUroflowmeter876.1800216
FFGDevice, Urine Flow Rate Measuring, Non-Electrical, Disposable876.1800217
KPNAlarm, Conditioned Response Enuresis876.2040237
OQTProstate Lesion, Documentation, System876.205021
QEFPressure Ulcer Management Tool876.210011
FHWDevice, Impotence, Mechanical/Hydraulic876.335031
JCWProsthesis, Penis, Inflatable876.335031
QGAPenile Implant Surgical Accessories876.350010
FAEProsthesis, Penile876.3630232
FTQProsthesis, Penis, Rigid Rod876.363022
FAFProsthesis, Testicular876.375031
FTOProsthesis, Testicle876.375030
FCSLight, Catheter, Fiberoptic, Glass, Ureteral876.4020210
QEJFlushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries876.410022
EZPRod, Colostomy876.427022
FARUnit, Electrosurgical876.430020
FASElectrode, Electrosurgical, Active, Urological876.4300258
FBJCord, Electric For Transurethral Surgical Instrument876.430020
FDBPlate, Patient876.430020
FDISnare, Flexible876.4300263
FDJSnare, Rigid Self-Opening876.430020
FDLWristlet, Patient Return876.430020
FEHElectrode, Flexible Suction Coagulator876.430023
FFISystem, Alarm, Electrosurgical876.430021
FGWClamp, Electrical876.430020
FHCAdaptor To The Cord, For Transurethral Surgical Instrument876.430020
FHYJelly, Contact, For Transurethral Surgical Instrument876.430020
FHZDesiccator, Transurethral876.430020
KGEForceps, Biopsy, Electric876.4300246
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)876.43002187
NLRUnit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed876.430021
NLTSnare, Flexible, Reprocessed876.430020
NLUForceps, Biopsy, Electric, Reprocessed876.430024
NLVElectrode, Flexible Suction Coagulator, Reprocessed876.430020
NLWElectrode, Electrosurgical, Active, Urological, Reprocessed876.430021
NWIElectrosurgical Electrode Kit876.430020
OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia876.430020
OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia876.430020
QECForceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree876.430021
QNEEndoscopic Pancreatic Debridement Device876.433021
PLPHigh Intensity Ultrasound System For Prostate Tissue Ablation876.4340213
FFDEvacuator, Bladder, Manually Operated876.437012
FHFSystem, Evacuator, Fluid876.437023
KQTEvacuator, Gastro-Urology876.4370214
PRUGastric Lavage Kit (Adult Or Pediatric Use)876.437020
FHNLigator, Hemorrhoidal876.4400222
MNDLigator, Esophageal876.4400215
PKLHemostatic Metal Clip For The Gi Tract876.4400262
QSWEndoscopic Traction Device876.441022
FEOLithotriptor, Ultrasonic876.4480214
FFKLithotriptor, Electro-Hydraulic876.4480261
FGKTripsor, Stone, Bladder876.450021
LQCLithotriptor, Biliary Mechanical876.4500211
FDGRetractor, Fiberoptic876.453012
EYSRibdam876.456010
FBSSound, Metal, Interconnected876.459011
FADStent, Ureteral876.46202122
QGBUreteral Stent Accessories876.463010
FFESystem, Water Jet Catheter, Renal876.465021
FFLDislodger, Stone, Basket, Ureteral, Metal876.4680252
FGODislodger, Stone, Flexible876.4680219
NQTDislodger, Stone, Flexible, Ureteral, Reprocessed876.468020
NQUDislodger, Stone, Basket, Ureteral, Metal, Reprocessed876.468020
NQVCatheter, Suction, Tracheobronchial, Reprocessed876.468010
ONJDissolvable Gel For Preventing Ureteral Stone Migration876.468021
QNAUltrasonic Urinary Stone Propulsion Device876.469021
EXXProbe, Rectal, Non-Powered876.473010
FCHTray, Biopsy, Without Biopsy Instruments876.473012
FFNClamp, Non-Electrical876.473015
FFORetractor, Self-Retaining876.473015
FFQSpeculum, Rectal876.473011
FFRDevice, Locking, For Intestinal Clamp876.473010
FGMProbe And Director, Gastro-Urology876.473017
FGNRetractor, Non-Self-Retaining876.473010
FGXSnare, Non-Electrical876.473010
FHBHook, Gastro-Urology876.473010
FHHCrusher, Spur, Colostomy876.473010
FHIRing, Laparotomy876.473010
FHKSpreader, Bladder Neck876.473010
FHLScoop876.473010
FHQHolder, Needle, Gastroenterologic876.473017
FKKClamp, Line876.473016
KOASurgical Instruments, G-U, Manual (And Accessories)876.4730144
OLHOrchidometer876.473010
OOWApplicator For Rectal Suppository876.473011
PVYVasovasostomy Set876.473010
EZOUrethrotome876.477025
EYDStirrups876.489010
EYHTable, Cysto, Non-Electrical876.489010
KQSTable, Cystometric, Non-Electric And Accessories876.489018
MMZTable, Cystometric, Electric876.489024
EXFBag, Bile Collecting876.501029
FGEStents, Drains And Dilators For The Biliary Ducts876.50102473
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection876.5010225
LQRDislodger, Stone, Biliary876.5010238
NMLCatheter, Biliary, Reprocessed876.501021
PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt876.501020
PNBBiliary Stent System For Benign Strictures876.501121
QGEBiliary Stent, Drain, And Dilator Accessories876.501210
PCUPancreatic Stent, Covered, Metallic, Removable876.5015211
QXHGallbladder Drainage Stent And Delivery System876.501621
LKYDevice, External Penile Rigidity876.5020287
QWWNon-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.876.502121
PIAVibrator For Climax Control Of Premature Ejaculation876.502521
QRCNon-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation876.502624
KPHCatheter, Rectal For Continent Ileostomy876.503011
FBMCannula And Trocar, Suprapubic, Non-Disposable876.509019
FBQTrocar, Gastro-Urology876.509029
FEWCatheter, Malecot876.509026
FEXInstrument, Catheter, Punch876.509012
FEZCatheter And Tube, Suprapubic876.509021
FFATube, Drainage, Suprapubic876.509023
KOBCatheter, Suprapubic (And Accessories)876.5090232
NWPSuprapubic Cystostomy Catheter Kit876.509020
QGCSuprapubic Catheter Accessories876.510010
EYAStylet, Ureteral876.513010
EYBCatheter, Ureteral, Gastro-Urology876.5130228
EYCCatheter, Upper Urinary Tract876.513025
EYIAdaptor, Ureteral Catheter876.513010
EYJHolder, Ureteral Catheter876.513010
EYKConnector, Ureteral Catheter876.513011
EZBStylet For Catheter, Gastro-Urology876.513013
EZCCatheter, Coude876.513027
EZDCatheter, Straight876.5130280
EZLCatheter, Retention Type, Balloon876.51302128
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)876.5130259
FGFCatheter, Ureteral Disposable (X-Ray)876.513021
FGHCatheter, Double Lumen Female Urethrographic876.513021
FGICatheter, Urethrographic, Male876.513023
GBLCatheter, Ureteral, General & Plastic Surgery876.5130N0
GBMCatheter, Urethral876.5130271
KNYAccessories, Catheter, G-U876.5130264
KODCatheter, Urological876.51302238
LJHSystem, Irrigation, Urological876.5130228
MJCCatheter, Urological (Antimicrobial) And Accessories876.5130210
NWOKit, Catheter, Urinary (Exludes Hiv Testing)876.513021
OHRCatheter Care Tray876.513020
PPABladder Irrigation Kit876.513020
PPBFoley Catheter Kit (Excludes Hiv Testing)876.513020
PPCMale External Catheterization Kit (Excludes Hiv Testing)876.513020
PPDUniversal Drainage Tray876.513020
PPFUrinary Irrigation Kit876.513020
PPGUrinary Drainage Collection Kit876.513020
SCTFoley Catheters And Accessories With Additional Safety Features876.513020
PIHUrethral Insert With Pump For Bladder Drainage876.514021
FHAClamp, Penile876.5160111
MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female876.516017
FCDBarium Enema Kit876.521012
FCEEnema Kit876.5210130
KPLColonic Irrigation System876.5220240
NUBColonic Irrigation System, General Well Being876.522030
EXIDevice, Paste-On For Incontinence, Sterile876.525017
EXJDevice, Incontinence, Urosheath Type, Sterile876.5250122
EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile876.525014
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile876.5250114
FAQBag, Urine Collection, Leg, For External Use, Sterile876.5250118
FCNUrinary Drainage Collection Kit, For Indwelling Catheter876.5250210
FFHCollector, Urine, Pediatric, For Indwelling Catheter876.525023
FOCBag, Urine Collection, Newborn876.525024
KNXCollector, Urine, (And Accessories) For Indwelling Catheter876.52502206
NNWBag, Urine Collection, Leg, For External Use, Non-Sterile876.525010
NNXDevice, Incontinence, Urosheath Type, Non-Sterile876.525010
NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile876.525010
NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile876.525010
NOADevice, Paste-On For Incontinence, Non-Sterile876.525010
NZUCollector, Urine, Powered, Non Indwelling Catheter876.525011
EZTPacemaker, Bladder876.527030
EZWStimulator, Electrical, Implantable, For Incontinence876.527034
QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence876.527032
EZYDevice, Incontinence, Mechanical/Hydraulic876.528032
QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories876.529010
QXMImplanted Tibial Electrical Urinary Continence Device876.530523
NAMStimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence876.531028
KPIStimulator, Electrical, Non-Implantable, For Incontinence876.5320292
QAJCutaneous Electrode Stimulator For Urinary Incontinence876.533025
QHHNon-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)876.534026
QJNLaparoscopic Accessories, Esophageal Sizing876.536022
EZMDilator, Esophageal (Metal Olive) Gastro-Urology876.536520
FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology876.536528
KNQDilator, Esophageal876.5365240
PRQEsophageal Dilator Kit876.536520
FFPDilator, Rectal876.545015
PSJRectal Dilator Kit876.545010
EZNDilator, Catheter, Ureteral876.5470256
QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia876.551023
FAHDilator, Urethral, Mechanical876.552024
FAXBougie, Urological876.552012
FBRUrethrometer876.552010
FBWFiliform And Filiform Follower876.552011
FBXSound, Urethral, Metal Or Plastic876.552011
KOEDilator, Urethral876.5520227
PEWImplantable Transprostatic Tissue Retractor System876.5530211
FIENeedle, Fistula876.5540279
FIQCannula, A-V Shunt876.5540223
FJMGuard, Shunt876.554020
FJNStabilizer, Shunt876.554020
FJOPlier, Tube876.554010
FJQConnector, Shunt876.554013
FJRForceps, Disconnect876.554010
FJWRing, Joint876.554010
FJXRing, Crimp876.554010
FJYPlier, Crimp876.554010
FKADilator, Vessel876.554023
FKCClamp, Cannula876.554011
FKNAdaptor, Shunt876.554024
FKWTip, Vessel876.554023
KNRAdapter, A-V Shunt Or Fistula876.554021
KNZAccessories, A-V Shunt876.5540210
LBWSet, Dialysis, Single Needle (Co-Axial Flow)876.554025
LFJCatheter, Subclavian876.5540265
LFKCatheter, Femoral876.5540216
MPBCatheter, Hemodialysis, Non-Implanted876.5540238
MSDCatheter, Hemodialysis, Implanted876.55402124
NFKKit, Repair, Catheter, Hemodialysis876.5540211
NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted876.5540212
NIFCatheter, Hemodialysis, Triple Lumen, Implanted876.554020
NNENeedle, Fistula, Reprocessed876.554020
NOOClamp, Dialysis Arm876.554010
NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use876.554024
NYUCatheter, Hemodialysis, Implanted, Coated876.554022
PEHHemodialysis Catheter Luer End Cap876.554022
PFHVenous Window Needle Guide876.554021
PKIFully Subcutaneous Implanted Hemodialysis Catheter876.554020
PPOMulti-Lumen Hemodialysis Catheterization Kit876.554020
NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia876.555024
FKTSystem, Dialysate Delivery, Sorbent Regenerated876.5600219
FJSCatheter, Peritoneal, Long-Term Indwelling876.5630248
FKOCatheter, Peritoneal Dialysis, Single Use876.5630216
FKXSystem, Peritoneal, Automatic Delivery876.5630283
KDJSet, Administration, For Peritoneal Dialysis, Disposable876.56302113
KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal876.5630213
KPPPeritoneal Dialysate Filter876.563023
MLWWarmer, Peritoneal Dialysate876.563026
PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling876.5630215
PPJPeritoneal Dialysis Administration Kit876.563020
PPKPeritoneal Dialysis Tubing Kit876.563020
PTUCatheter, Peritoneal, Long-Term Indwelling, Exempt876.563020
PTVCatheter, Peritoneal Dialysis, Single Use, Exempt876.563020
PTWSystem, Peritoneal, Automatic Delivery, Exempt876.563020
FIPSubsystem, Water Purification876.56652117
MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant876.5665213
MSZStrip, Test, Reagent, Residuals For Dialysate876.566520
NHVSystem, Water Purification, General Medical Use876.5665211
NIHDisinfectant, Subsystem, Water Purification876.566521
PSXChlorine Meter876.566521
FHSDialyzer, Single Coil876.5820212
FIAChair, Dialysis, Unpowered, Without Scales876.582010
FIBProtector, Transducer, Dialysis876.5820235
FIDTubing, Dialysate876.582023
FIFSet, Dialysis, Single Needle With Uni-Directional Pump876.582026
FIGClamp, Tubing, Blood, Automatic876.582024
FIHPump, Infusion Or Syringe, Extra-Luminal876.582025
FIJSystem, Dialysate Delivery, Recirculating, Single Pass876.582021
FIKSystem, Dialysate Delivery, Recirculating876.582020
FILSystem, Dialysate Delivery, Single Pass876.582028
FINTank, Holding, Dialysis876.5820218
FIRPump, Blood, Extra-Luminal876.582027
FISFlowmeter, Dialysate876.582020
FIWAlarm, Pillow Pressure876.582021
FIZMeter, Conductivity, Non-Remote876.5820213
FJAManometer, Water876.582020
FJBDetector, Dialysate Level876.582023
FJCDetector, Blood Level876.582021
FJDDetector, Leak, Blood876.582024
FJFDetector, Air Bubble876.582025
FJGDialyzer, Parallel Flow876.5820236
FJIDialyzer, Capillary, Hollow Fiber876.58202131
FJJDialyzer, Twin Coil876.582020
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve876.5820276
FJPAdaptor, Y876.582020
FJTIntracatheter, Dialysis876.582025
FJZDeclotting Tray, Kit (Including Contents)876.582023
FKBConnector, Blood Tubing, Infusion T876.582022
FKDCanister, Coil876.582021
FKETie, Dialysis876.582010
FKFGun, Tie, Dialysis876.582010
FKGTray, Start/Stop (Including Contents), Dialysis876.582016
FKHSolution-Test Standard-Conductivity, Dialysis876.582028
FKISet, Dialyzer Holder876.582023
FKJFilter, Blood, Dialysis876.582025
FKLInsert, Pump, Blood876.582021
FKMAdaptor, Fistula876.582020
FKPSystem, Dialysate Delivery, Single Patient876.5820250
FKQSystem, Dialysate Delivery, Central Multiple Patient876.5820261
FKRSubsystem, Proportioning876.5820212
FKYConnector, Tubing, Dialysate876.582024
FLAMonitor, Temperature, Dialysis876.582023
FLBMeter, Conductivity, Induction, Remote Type876.582026
FLCStation, Dialysis Control, Negative Pressure Type876.582024
KOCAccessories, Blood Circuit, Hemodialysis876.58202182
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)876.58202123
KQQTubing, Dialysate (And Connector)876.582021
KQRDetector, Air Or Foam876.582020
KXMSystem Accessories, Extracorporeal876.582024
LIFDialyzer Reprocessing System876.5820257
LLBSystem, Blood, Extracorporeal And Accessories876.582022
LRIPh Meter For Dialysis Hydrogen Ion Concentration876.582021
MNVStrip, Dialysate Ph Indicator876.582026
MONSystem, Hemodialysis, Remote Accessories876.582010
MQSSystem, Hemodialysis, Access Recirculation Monitoring876.5820218
MSEHemodialyzer, Re-Use, Low Flux876.582027
NNGSet, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed876.582020
NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator876.582021
ODXAutonomous Extracorporeal Blood Leak Detector/Alarm876.582024
PEVDialysis Administration Kit876.582020
PPHSingle Needle With Uni-Directional Pump Kit876.582020
PPIHemodialysis Tray (Not A Start/Stop Kit)876.582020
PPLSingle Needle (Co-Axial Flow) Dialysis Kit876.582020
PROAnti-Regurgitation Blood Tubing Kit876.582020
FJHDialyzer, Disposable876.583024
FIISystem, Dialysate Delivery, Sealed876.586025
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System876.58602343
MSFHemodialyzer, Re-Use, High Flux876.586028
NIIDisinfectant, Dialysate Delivery System876.586022
ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System876.586022
ONWHemodialysis System For Home Use876.586024
QIRPediatric Hemodialysis System876.586121
QAXHemodialyzer With Expanded Solute Removal Profile876.586221
FLDApparatus, Hemoperfusion, Sorbent876.5870211
KDKContainer, Transport, Kidney876.588023
KDLSet, Perfusion, Kidney, Disposable876.5880219
KDNSystem, Perfusion, Kidney876.5880242
MSBSystem And Accessories, Isolated Heart, Transport And Preservation876.5880213
PINKidney Perfusion Kit876.588020
SGYHypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant876.588121
NDSMedia, Culture, Ex Vivo, Tissue And Cell876.588529
EXDIrrigator, Ostomy876.5895212
EXASelector, Size, Ostomy876.590011
EXBCollector, Ostomy876.59001102
EXEProtector, Ostomy876.590013
EXGBag, Urine Collecting, Ureterostomy876.590010
EXHBag, Urinary, Ileostomy876.590010
EZQPouch, Colostomy876.590016
EZRCement, Stomal Appliance, Ostomy876.590016
EZSAppliance, Colostomy, Disposable876.590011
FONBag, Drainage, With Adhesive, Ostomy876.590013
GDSBag, Stomal876.590012
PQEOstomy Care Kit876.590010
EYQGarment, Protective, For Incontinence876.5920156
PJHDynamic Rectal Control System876.593022
QTNOrally Ingested Transient Device For Constipation876.594023
KPMShunt, Peritoneal876.5955219
QMYComputerized Behavioral Therapy Device For Treating Symptoms876.596023
EXMTruss, Umbilical876.597010
EXNSupport, Hernia876.597011
BSSTube, Nasogastric876.5980213
EYNTray, Irrigation, Sterile876.5980215
EZKCatheter, Retention Type876.598023
FCBBag, Hemostatic876.598020
FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression876.598021
FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation876.5980213
FFWString And Tubes, Gastrointestinal, To Locate Internal Bleeding876.598020
FGDCatheter, Retention, Barium Enema With Bag876.598026
FHTSet, Gavage, Infant, Sterile876.598021
FPDTube, Feeding876.5980259
FRQTube, Levine876.598023
GBTCatheter, Rectal876.598023
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration876.5980223
KGCTube, Gastro-Enterostomy876.5980226
KNTTubes, Gastrointestinal (And Accessories)876.59802649
LCGIntestinal Splinting Tubes876.598020
LEYSet, Oral Administration876.598021
NGUBalloon, Liver Tamponade876.598021
PBPRectal Insert876.598022
PIDEsophageal Dilator Balloon With Or Without Electrode Sensors876.598023
PIEEsophageal Dilator With Balloon And Electrode Sensors876.598022
PIFGastrointestinal Tubes With Enteral Specific Connectors876.5980250
PIOEnteral Specific Transition Connectors876.598029
PLIGastrointestional Tube Holder876.598021
PNREnteral Syringes With Enteral Specific Connectors876.5980234
PRMEnteral Administration Kit (Adult & Pediatric)876.598020
PRPBalloon Gastrostomy Tube Kit876.598020
PRRFeeding Tube Kit876.598020
PRSGastric Colonic Catheter Irrigation Kit876.598020
PRTGastric Irrigation And Aspiration Kit876.598020
PRWGastrointestinal Tube Kit876.598020
PRXGastrostomy Guide Wire Placement Kit876.598020
PRYGastrostomy Jejunostomy Feeding Tube Kit876.598020
PRZGastrostomy Tube Kit876.598020
PSALaparoscopic Jejunostomy Kit876.598020
PSBNasogastric Feed Tube Kit876.598020
PSCNasogastric-Gastrojejunal Kit876.598020
PSDLaparoscopic Gastrostomy Kit876.598020
PSENeedle Catheter Jejunostomy Kit876.598020
PSFNon-Balloon Replacement Gastrostomy System876.598020
PSGPercutaneous Endoscopic Gastrostomy Kit876.598020
PSHPercutaneous Replacement Gastrostomy Tube Kit876.598020
PSIPerineal Irrigation Kit876.598020
PSKReplacement Gastrostomy Feeding Catheter Tray876.598020
PTKPediatric Esophageal Atresia Anastomosis Device876.598030
ONYOral Removable Retainer For Weight Management876.598122
QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss876.598223
QTDEndoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss876.598322
SFWCranial Electrotherapy Stimulator For Weight Management876.598411
PLQEnzyme Packed Cartridge876.598528
LNSLithotriptor, Extracorporeal Shock-Wave, Urological876.5990268
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