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

5373 Gastroenterology & Urology devices

2651–2675 of 5373

Cleared Sep 02, 1999

RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18

K990867 · Advanced Cardiovascular Systems, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 170d

Cleared Sep 01, 1999

ENDIUS SUCTION/IRRIGATION INSTRUMENT

K992535 · Endius, Inc.

OCX · Endoscopic Irrigation/suction System · 34d

Cleared Aug 30, 1999

RENACLEAR DIALYZER CLEANING SYSTEM

K991851 · Minntech Corp.

LIF · Dialyzer Reprocessing System · 90d

Cleared Aug 24, 1999

TRIP TONOMETRY CATHETER, 8F

K992181 · Datex-Ohmeda, Inc.

KNT · Tubes, Gastrointestinal (and Accessories) · 57d

Cleared Aug 18, 1999

KSEA CALCUSPLIT

K992114 · Karl Storz Endoscopy

FFK · Lithotriptor, Electro-hydraulic · 57d

Cleared Aug 17, 1999

MAMMOTOME HH HAND-HELD PROBE, VACUUM SET, CONTROL MODULE, HH HAND-HELD HOLSTER AND CABLES, SOFTWARE PACKAGE, FOOTSWITCH,

K991980 · Ethicon Endo-Surgery, Inc.

KNW · Instrument, Biopsy · 64d

Cleared Aug 12, 1999

CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS

K991674 · Cordis Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 87d

Cleared Aug 09, 1999

NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA

K991623 · Nipro Medical Corp.

FIE · Needle, Fistula · 90d

Cleared Aug 04, 1999

CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES

K991028 · Cordis Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 128d

Cleared Aug 04, 1999

FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS

K992275 · Fresenius USA, Inc.

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 28d

Cleared Jul 30, 1999

FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION

K991520 · Fresenius Medical Care North America

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 88d

Cleared Jul 14, 1999

ELECTRO MECHANICAL LITHOTRIPTOR

K990341 · Northgate Technologies, Inc.

FFK · Lithotriptor, Electro-hydraulic · 161d

Cleared Jul 12, 1999

MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY

K982326 · Boston Scientific Corp

MSD · Catheter, Hemodialysis, Implanted · 375d

Cleared Jul 06, 1999

SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR

K991323 · Smith & Nephew, Inc.

FFS · Image, Illumination, Fiberoptic, For Endoscope · 78d

Cleared Jul 02, 1999

DD URETERAL STENT, INTEGRAL STENT

K982974 · Rusch Intl.

FAD · Stent, Ureteral · 311d

Cleared Jun 29, 1999

K991314 · American Medical Systems, Inc.

FAS · Electrode, Electrosurgical, Active, Urological · 74d

Cleared Jun 25, 1999

ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM

K991793 · AngioDynamics, Inc.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d

Cleared Jun 22, 1999

WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM

K991056 · Boston Scientific Corp

MQR · Stent, Colonic, Metallic, Expandable · 84d

Cleared Jun 21, 1999

C-FLEX URETERAL STENTS

K991219 · Applied Medical Resources

FAD · Stent, Ureteral · 70d

Cleared Jun 18, 1999

K990953 · Baxter Healthcare Corp

KPF · System, Dialysate Delivery, Semi-automatic, Peritoneal · 88d

Cleared Jun 11, 1999

COOPERSURGICAL INFRARED COAGULATOR

K990852 · CooperSurgical, Inc.

KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 88d

Cleared Jun 11, 1999

SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228

K990864 · Boston Scientific Corp

MND · Ligator, Esophageal · 87d

Cleared Jun 11, 1999

FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253

K991178 · Richard Wolf Medical Instruments Corp.

FGB · Ureteroscope And Accessories, Flexible/rigid · 65d

Cleared Jun 10, 1999

11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT

K980438 · Medical Components, Inc.

MPB · Catheter, Hemodialysis, Non-implanted · 491d

Cleared Jun 08, 1999

SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH

K983511 · Medical Components, Inc.

MPB · Catheter, Hemodialysis, Non-implanted · 244d

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