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

9843

Total

9796

Cleared

154d

Avg (2y)

1976

Since

2657 Gastroenterology & Urology devices

2351–2375 of 2657

Cleared Jun 17, 1988

MODIFIED COPE SUTURE ANCHOR

K873606 · Cook, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 283d

Cleared May 31, 1988

DENVER PERITONEO-VENOUS SHUNT

K880401 · Codman & Shurtleff, Inc.

KPM · Shunt, Peritoneal · 123d

Cleared May 26, 1988

BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS

K880102 · Baxter Healthcare Corp

KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 135d

Cleared May 06, 1988

BARD (R) ESKA ERECTIOMETER

K880903 · C.R. Bard, Inc.

LIL · Monitor, Penile Tumescence · 65d

Cleared Apr 27, 1988

MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA

K881290 · Shiley, Inc.

LFJ · Catheter, Subclavian · 30d

Cleared Apr 27, 1988

DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH

K881332 · Baxter Healthcare Corp

OCZ · Endoscopic Grasping/cutting Instrument, Non-powered · 29d

Cleared Feb 22, 1988

MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH

K880583 · Quinton, Inc.

MPB · Catheter, Hemodialysis, Non-implanted · 13d

Cleared Feb 17, 1988

PERMCATH INSERTION TRAY

K874633 · Quinton, Inc.

LFJ · Catheter, Subclavian · 100d

Cleared Jan 29, 1988

ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE

K874020 · Abbott Laboratories

KPF · System, Dialysate Delivery, Semi-automatic, Peritoneal · 119d

Cleared Jan 29, 1988

CAPILLARY FLOW DIALYZERS

K874728 · Baxter Healthcare Corp

FJI · Dialyzer, Capillary, Hollow Fiber · 72d

Cleared Dec 29, 1987

BENT NECK CURLCATH PERITONEAL DIALYSIS KIT

K874632 · Quinton, Inc.

FKX · System, Peritoneal, Automatic Delivery · 50d

Cleared Dec 09, 1987

PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)

K874650 · Quinton, Inc.

FKO · Catheter, Peritoneal Dialysis, Single Use · 26d

Cleared Nov 30, 1987

OLYMPUS LUS ULTRASONIC LITHOTRIPTER

K873367 · Olympus Corp.

FEO · Lithotriptor, Ultrasonic · 101d

Cleared Oct 20, 1987

AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)

K873984 · Travenol Laboratories, S.A.

KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 20d

Cleared Oct 13, 1987

HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309

K872364 · Travenol Laboratories, S.A.

FII · System, Dialysate Delivery, Sealed · 117d

Cleared Sep 30, 1987

UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

K872652 · Travenol Laboratories, S.A.

FKX · System, Peritoneal, Automatic Delivery · 85d

Cleared Aug 26, 1987

FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM

K871846 · Abbott Laboratories

KNT · Tubes, Gastrointestinal (and Accessories) · 106d

Cleared Aug 25, 1987

CODMAN FLEXIBLE ENDOSCOPE

K871978 · Codman & Shurtleff, Inc.

GCQ · Endoscope, Flexible · 95d

Cleared Jun 17, 1987

ADULT PERM-CATH 40CM.

K871749 · Quinton, Inc.

LFJ · Catheter, Subclavian · 43d

Cleared Jun 17, 1987

PERM-CATH CATHETER KIT

K871942 · Quinton, Inc.

LFJ · Catheter, Subclavian · 29d

Cleared Jun 12, 1987

CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15

K871471 · Travenol Laboratories, S.A.

FJI · Dialyzer, Capillary, Hollow Fiber · 59d

Cleared Jun 05, 1987

BARD BIOPTY BIOPSY SYSTEM

K871390 · C.R. Bard, Inc.

KNW · Instrument, Biopsy · 59d

Cleared May 18, 1987

MODIFIED USE OF PULL-APART INTRODUCER SET

K871730 · Quinton, Inc.

FKO · Catheter, Peritoneal Dialysis, Single Use · 13d

Cleared May 11, 1987

SINGLE LUMEN ACUTE CATHETER

K870328 · Quinton, Inc.

LFJ · Catheter, Subclavian · 103d

Cleared Apr 29, 1987

10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE

K871360 · Quinton, Inc.

MPB · Catheter, Hemodialysis, Non-implanted · 23d

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