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

2601–2625 of 2657

Cleared Jan 26, 1978

QUADRIPLEGIC URINARY DRAINAGE VALVE

K772402 · Fred Sammons, Inc.

FAQ · Bag, Urine Collection, Leg, For External Use, Sterile · 30d

Cleared Jan 26, 1978

K772405 · Fred Sammons, Inc.

FFN · Clamp, Non-electrical · 30d

Cleared Jan 17, 1978

URINARY LEG BAG

K780032 · C.R. Bard, Inc.

FAQ · Bag, Urine Collection, Leg, For External Use, Sterile · 8d

Cleared Jan 03, 1978

PATIENT BY-PASS

K771422 · Quinton, Inc.

FJQ · Connector, Shunt · 155d

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 Nov 28, 1977

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 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

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

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 04, 1977

NEEDLE HOLDER, MICROVASCULAR

K771859 · Edward Weck, Inc.

FHQ · Holder, Needle, Gastroenterologic · 5d

Cleared Sep 30, 1977

COLORPLAST TRANSVERSE SYSTEM

K771775 · C.R. Bard, Inc.

EXB · Collector, Ostomy · 11d

Cleared Sep 15, 1977

PRESSURE MODULE 5M1247

K771375 · Travenol Laboratories, S.A.

FKQ · System, Dialysate Delivery, Central Multiple Patient · 52d

Cleared Sep 15, 1977

EMODIALYSIS DEL. SYS. MODEL 7110

K771696 · Bd Becton Dickinson Vacutainer Systems Preanalytic

FKP · System, Dialysate Delivery, Single Patient · 9d

Cleared Aug 26, 1977

K771419 · Quinton, Inc.

FKC · Clamp, Cannula · 25d

Cleared Aug 26, 1977

TUBE OCCLUDING FORCEPS

K771424 · Quinton, Inc.

KOC · Accessories, Blood Circuit, Hemodialysis · 25d

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