Subpart F—Therapeutic Devices

FDA submissions for Subpart F—Therapeutic Devices in the Gastroenterology, Urology (GU) review panel, including product codes and regulations.

Section range: §§ 876.5010–876.5990

CFR Part: 876

Product Codes

Product CodeDevice NameRegulationClassDevices
EXFBag, Bile Collecting876.501029
FGEStents, Drains And Dilators For The Biliary Ducts876.50102474
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, Straight876.5130281
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
Innolitics

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