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

9917

Total

9869

Cleared

154d

Avg (2y)

1976

Since

8478 Gastroenterology & Urology devices

6576–6600 of 8478

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

Cleared Mar 07, 1990

BALLOON DILATION CATHETER

K896448 · Cook Ob/Gyn

EZN · Dilator, Catheter, Ureteral · 118d

Cleared Mar 07, 1990

WILSON-COOK COLON DECOMPRESSION SET

K900035 · Wilson-Cook Medical, Inc.

FEG · Tube, Double Lumen For Intestinal Decompression And/or Intubation · 64d

Cleared Mar 06, 1990

AMS DYNAFLEX SELF CONTAINED PENILE PROSTHESIS

K896941 · American Medical Systems, Inc.

FAE · Prosthesis, Penile · 83d

Cleared Mar 06, 1990

MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS

K900031 · Porges Corp.

KNY · Accessories, Catheter, G-u · 61d

Cleared Mar 02, 1990

DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1

K900005 · National Medical Care, Medical Products Div., Inc.

KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 59d

Cleared Feb 27, 1990

QUICK DISCONNECT CLAMP CATALOG NO. 48-0300-3

K896956 · National Medical Care, Medical Products Div., Inc.

KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 75d

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