Subpart B—Diagnostic Devices

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

Section range: §§ 876.1050–876.1800

CFR Part: 876

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
Innolitics

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