Subpart E—Surgical Devices

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

Section range: §§ 876.4020–876.4890

CFR Part: 876

Product Codes

Product CodeDevice NameRegulationClassDevices
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)876.43002188
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 Tract876.4400263
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
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