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
5376 Gastroenterology & Urology devices
3776–3800 of 5376
Cleared May 02, 1990
DYNA-FLO URINARY DRAINAGE BAG
K896695 · Medline Industries, Inc.
EYZ · System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile · 155d
Cleared May 02, 1990
MAGNET RETRIEVAL CATHETER
K900852 · Cook, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 69d
Cleared Apr 25, 1990
DUAL LUMEN SUB-CLAVIAN CATHETERS DLSC 600S & 800S
K900803 · Akcess Medical Products, Inc.
LFJ · Catheter, Subclavian · 64d
Cleared Apr 19, 1990
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038 · Baxter Healthcare Corp
FIL · System, Dialysate Delivery, Single Pass · 44d
Cleared Apr 17, 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · C.R. Bard, Inc.
KOD · Catheter, Urological · 90d
Cleared Apr 09, 1990
WILSON-COOK CYTOLOGY BRUSHES
K896318 · Wilson-Cook Medical, Inc.
FDX · Endoscopic Cytology Brush · 159d
Cleared Apr 09, 1990
WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
K896323 · Wilson-Cook Medical, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 159d
Cleared Mar 29, 1990
BARD/ANGIOMED STENTS
K896391 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 143d
Cleared Mar 23, 1990
DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
K895792 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 176d
Cleared Mar 23, 1990
CATHETER EXTENSION SET CAT. NO. 48-3027-9
K895992 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 161d
Cleared Mar 22, 1990
DEXTROLYTE II PERITONEAL DIALYSIS CYCLER SET
K895990 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 160d
Cleared Mar 22, 1990
PERITONEAL DIALYSIS DRAINAGE SET NO. 48-0025-6
K895991 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 160d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET -(8)
K896599 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 121d
Cleared Mar 22, 1990
DEXTROLYTE II, SINGLE USE Y SET NO. 48-6360-1
K896600 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 121d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
K900008 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 79d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET
K900012 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 79d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS CYCLER SET W/3
K900140 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1100-6
K900141 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, W/5 PRONG MANIFOLD NO. 48-1003-2
K900142 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 70d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1001-6
K900226 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 64d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1031-3
K900242 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 64d
Cleared Mar 22, 1990
DEXTROLYTE II, PERITONEAL DIALYSIS NO. 48-1015-6
K900243 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 64d
Cleared Mar 22, 1990
PERITONEAL DIALYSIS CYCLER SET
K900323 · National Medical Care, Medical Products Div., Inc.
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 58d
Cleared Mar 19, 1990
HEMORRHOIDAL LIGATOR WITH SUCTION
K900086 · Baxter Healthcare Corp
KDH · Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration · 74d
Cleared Mar 13, 1990
INFANT FEEDING TUBE
K896559 · Westmark, Sterile Packing Systems, Inc. (Sps)
FPD · Tube, Feeding · 116d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices

Filter by Product Code

All categories 5376 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