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

8490 Gastroenterology & Urology devices

6976–7000 of 8490

Cleared Jul 21, 1987

WASHING/INJECTION NEEDLE

K872060 · Endovations

FBK · Endoscopic Injection Needle, Gastroenterology-urology · 54d

Cleared Jul 16, 1987

DELFLEX RIGID DRAIN CONTAINER

K871155 · Delmed, Inc.

KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 114d

Cleared Jul 16, 1987

VAS-CATH PERITONEAL DIALYSIS CATHETER

K871817 · Vas-Cath of Canada , Ltd.

FJS · Catheter, Peritoneal, Long-term Indwelling · 66d

Cleared Jun 17, 1987

ADULT PERM-CATH 40CM.

K871749 · Quinton, Inc.

LFJ · Catheter, Subclavian · 43d

Cleared Jun 17, 1987

VAN-TEC REUSABLE HELICAL STONE BASKET

K871777 · Van-Tec, Inc.

FFL · Dislodger, Stone, Basket, Ureteral, Metal · 42d

Cleared Jun 17, 1987

HELICAL STONE BASKET (DISPOSABLE)

K871779 · Van-Tec, Inc.

FFL · Dislodger, Stone, Basket, Ureteral, Metal · 42d

Cleared Jun 17, 1987

PERM-CATH CATHETER KIT

K871942 · Quinton, Inc.

LFJ · Catheter, Subclavian · 29d

Cleared Jun 12, 1987

SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE

K871348 · Sharplan Lasers, Inc.

LNK · Laser For Gastro-urology Use · 67d

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 12, 1987

VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH

K871487 · Vas-Cath of Canada , Ltd.

LFJ · Catheter, Subclavian · 58d

Cleared Jun 12, 1987

VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH

K871488 · Vas-Cath of Canada , Ltd.

LFJ · Catheter, Subclavian · 58d

Cleared Jun 10, 1987

SYNECTICS LIBERTY SYSTEM AMPLIFIER AND SOFTWARE

K871282 · Synectics-Dantec

FFT · Electrode, Ph, Stomach · 71d

Cleared Jun 10, 1987

CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML)

K871610 · Coloplast A/S

KNX · Collector, Urine, (and Accessories) For Indwelling Catheter · 47d

Cleared Jun 10, 1987

CONVEEN(R) LEG-BAG (600 ML)

K871643 · Coloplast A/S

KNX · Collector, Urine, (and Accessories) For Indwelling Catheter · 44d

Cleared Jun 09, 1987

ACTRIL FOR KIDNEY MACHINE DISINFECTANT

K861730 · Renal Systems, Inc.

FKQ · System, Dialysate Delivery, Central Multiple Patient · 399d

Cleared Jun 05, 1987

BARD BIOPTY BIOPSY SYSTEM

K871390 · C.R. Bard, Inc.

KNW · Instrument, Biopsy · 59d

Cleared Jun 03, 1987

FREEDOM SET II WITH TRIFLEX VALVE

K870626 · Delmed, Inc.

KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 110d

Cleared May 29, 1987

HOLLOW FIBER DIALYZER FOCUS 70,90,120,90H,120H

K871236 · National Medical Care, Medical Products Div., Inc.

FJI · Dialyzer, Capillary, Hollow Fiber · 63d

Cleared May 18, 1987

MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.

K871029 · Directed Energy, Inc.

LNK · Laser For Gastro-urology Use · 63d

Cleared May 18, 1987

MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.

K871032 · Directed Energy, Inc.

LNK · Laser For Gastro-urology Use · 63d

Cleared May 18, 1987

MODIFIED USE OF PULL-APART INTRODUCER SET

K871730 · Quinton, Inc.

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

Cleared May 15, 1987

MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.

K871030 · Directed Energy, Inc.

LNK · Laser For Gastro-urology Use · 60d

Cleared May 15, 1987

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH

K871031 · Directed Energy, Inc.

LNK · Laser For Gastro-urology Use · 60d

Cleared May 15, 1987

GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER

K871108 · Gambro, Inc.

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 57d

Cleared May 11, 1987

SINGLE LUMEN ACUTE CATHETER

K870328 · Quinton, Inc.

LFJ · Catheter, Subclavian · 103d

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