FDA Review Panel · GU

FDA 510(k) Gastroenterology & Urology Devices

FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview

FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.

Common device types:

  • GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
  • Biliary and pancreatic stents - metal and plastic biliary drainage devices
  • Urological devices - ureteral stents, catheters, stone retrieval baskets
  • Ablation systems - RFA and cryoablation for GI lesions
  • Anorectal devices - manometry systems, hemorrhoid treatment

9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5378 Gastroenterology & Urology devices
5201–5225 of 5378
Cleared Jan 03, 1978
A-V SHUNT EXTENSION
K771425 · Quinton, Inc.
FKN · Adaptor, Shunt · 155d
Cleared Jan 03, 1978
RINSE BLOCK CONNECTOR
K771482 · Quinton, Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 152d
Cleared Dec 22, 1977
DISP. TEFLON CONNHCTOR
K771429 · Quinton, Inc.
FJQ · Connector, Shunt · 143d
Cleared Dec 20, 1977
PEDIATRIC INFUSION T
K771426 · Quinton, Inc.
FKB · Connector, Blood Tubing, Infusion T · 141d
Cleared Dec 20, 1977
PERITONEAL CYCLER & MANIFOLD SET
K772136 · Physio-Control Corp.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 36d
Cleared Dec 20, 1977
T-TUBE WHELAN-MOSS
K772292 · Davol, Inc.
GCA · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection · 8d
Cleared Dec 13, 1977
CATHETER, SILICONE COATED
K772218 · Concord Laboratories, Inc.
EZL · Catheter, Retention Type, Balloon · 11d
Cleared Nov 28, 1977
BETA-CAP
K771420 · Quinton, Inc.
FJS · Catheter, Peritoneal, Long-term Indwelling · 119d
Cleared Nov 28, 1977
CATHETER FINGER GRIP
K771483 · Quinton, Inc.
FJS · Catheter, Peritoneal, Long-term Indwelling · 116d
Cleared Nov 28, 1977
CATHETER, DISP., EXTERNAL, MALE
K772144 · Medline Industries, Inc.
EXJ · Device, Incontinence, Urosheath Type, Sterile · 13d
Cleared Nov 28, 1977
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150 · C.R. Bard, Inc.
FKX · System, Peritoneal, Automatic Delivery · 14d
Cleared Nov 28, 1977
DIALYSIS MACHINES DM-346 & 346-1
K772163 · Extracorporeal Medical Specialities, Inc.
FIJ · System, Dialysate Delivery, Recirculating, Single Pass · 12d
Cleared Nov 22, 1977
PRESSURE MONITOR MANOMETRIC SYS.
K771265 · Physio-Control Corp.
KLA · Monitor, Esophageal Motility, Anorectal Motility, And Tube · 132d
Cleared Nov 22, 1977
HILL TUBE
K771723 · Physio-Control Corp.
KLA · Monitor, Esophageal Motility, Anorectal Motility, And Tube · 70d
Cleared Nov 22, 1977
WALL TRANSFORMERS 74710 & 74910
K771864 · Welch Allyn, Inc.
GCW · Transformer, Endoscope · 50d
Cleared Nov 16, 1977
URINARY DRAINAGE BAG 2D9017
K772113 · Travenol Laboratories, S.A.
EYZ · System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile · 9d
Cleared Oct 25, 1977
CATHETEO CLAMP
K771421 · Quinton, Inc.
FFN · Clamp, Non-electrical · 85d
Cleared Oct 25, 1977
RINSE BLOCK ASSEM, D-W PERI. DIALYSIS
K771484 · Quinton, Inc.
FKX · System, Peritoneal, Automatic Delivery · 82d
Cleared Oct 18, 1977
URI-DRAIN COMBO KIT FOR MALE INCONTINENC
K770789 · Chesebrough-Pond'S U.S.A. Co.
KNX · Collector, Urine, (and Accessories) For Indwelling Catheter · 168d
Cleared Oct 18, 1977
CATHETER, URETHERAL
K770814 · C.R. Bard, Inc.
KOD · Catheter, Urological · 168d
Cleared Oct 18, 1977
ENDOSCOPE, UROLOGICAL, FEMALE
K770943 · C.R. Bard, Inc.
FAL · Panendoscope (urethroscope) · 146d
Cleared Oct 18, 1977
TENCKHOFF PERITONEAL TUBING ADAPT.
K771428 · Quinton, Inc.
FKY · Connector, Tubing, Dialysate · 78d
Cleared Oct 18, 1977
UROFLOW-CYSTOMETER SYSTEM
K771850 · Richard Wolf Medical Instruments Corp.
FAP · Cystometric Gas (carbon-dioxide) On Hydraulic Device · 19d
Cleared Oct 05, 1977
CATHETERIZATION SYS. URINARY DRAINAGE
K771779 · Medical Devices, Inc.
KOD · Catheter, Urological · 14d
Cleared Oct 04, 1977
DIALYSIS MACHINE, CENTRY II
K770857 · Cobe Laboratories, Inc.
FJF · Detector, Air Bubble · 148d

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All categories 5378 FGE Stents, Drains And Dilators For The Biliary Ducts 314 KNT Tubes, Gastrointestinal (and Accessories) 302 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 217 KOD Catheter, Urological 130 KNW Instrument, Biopsy 122 KOC Accessories, Blood Circuit, Hemodialysis 121 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 116 FJI Dialyzer, Capillary, Hollow Fiber 96 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 94 FAD Stent, Ureteral 94 FGB Ureteroscope And Accessories, Flexible/rigid 89 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 81 FDF Colonoscope And Accessories, Flexible/rigid 71 EXB Collector, Ostomy 68 FED Endoscopic Access Overtube, Gastroenterology-urology 67