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

8436 Gastroenterology & Urology devices

4651–4675 of 8436

Cleared Mar 31, 1999

MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM

K990220 · Medi-Globe Corp.

FCG · Biopsy Needle · 68d

Cleared Mar 30, 1999

DAUM NEUROCUT NEUROBIOPSYNEEDLE

K990278 · Daum Corp.

KNW · Instrument, Biopsy · 61d

Cleared Mar 30, 1999

COOPERSURGICAL INFRARED COAGULATOR FOR ENT

K990855 · CooperSurgical, Inc.

KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 15d

Cleared Mar 26, 1999

GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS

K982414 · Gambro Healthcare

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 256d

Cleared Mar 26, 1999

URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042

K990050 · Richard Wolf Medical Instruments Corp.

FGB · Ureteroscope And Accessories, Flexible/rigid · 78d

Cleared Mar 26, 1999

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS

K990687 · Olympus Optical, Co.

PKL · Hemostatic Metal Clip For The Gi Tract · 25d

Cleared Mar 25, 1999

BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C

K990072 · Cook Urological, Inc.

EZN · Dilator, Catheter, Ureteral · 73d

Cleared Mar 25, 1999

WILSON-COOK BIPOLAR PROBE

K990145 · Wilson-Cook Medical, Inc.

KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 65d

Cleared Mar 25, 1999

ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP

K990456 · Hollister, Inc.

KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 41d

Cleared Mar 22, 1999

KSEA ENDOSCOPE HOLDER

K990334 · KARL STORZ Endoscopy-America, Inc.

OCV · Endoscope Holder · 47d

Cleared Mar 22, 1999

MOSS GASTROSTOMY TUBE

K990389 · Moss Tubes, Inc.

KNT · Tubes, Gastrointestinal (and Accessories) · 42d

Cleared Mar 18, 1999

GILTECH PLUS CONNECTING TUBE SET

K983624 · Giltech Plus, Inc.

KDH · Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration · 154d

Cleared Mar 17, 1999

MODIFICATION OF MOSS P.E.G. TRAY

K984628 · Moss Tubes, Inc.

KNT · Tubes, Gastrointestinal (and Accessories) · 77d

Cleared Mar 15, 1999

FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO

K990765 · Flexmedics

OCY · Endoscopic Guidewire, Gastroenterology-urology · 7d

Cleared Mar 08, 1999

FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS

K983126 · Minntech Corp.

FIP · Subsystem, Water Purification · 181d

Cleared Mar 05, 1999

RESTORE (AKA RE/STOR)

K983164 · Nebl, Inc.

MNG · External Urethral Occluder, Urinary Incontinence-control, Female · 176d

Cleared Mar 05, 1999

PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX

K984607 · Richard Wolf Medical Instruments Corp.

FBP · Telescope, Rigid, Endoscopic · 67d

Cleared Mar 03, 1999

GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38

K983075 · Guidant Corp.

FGE · Stents, Drains And Dilators For The Biliary Ducts · 182d

Cleared Mar 02, 1999

MOSS TUBES, INC. NASAL TUBE - MARK IV

K984629 · Moss Tubes, Inc.

BSS · Tube, Nasogastric · 62d

Cleared Mar 01, 1999

BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES

K983476 · Navion Biomedical Corp.

KNT · Tubes, Gastrointestinal (and Accessories) · 150d

Cleared Feb 26, 1999

MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6

K981125 · Medical Components, Inc.

MSD · Catheter, Hemodialysis, Implanted · 336d

Cleared Feb 24, 1999

HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)

K980386 · Gambro Healthcare

KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 387d

Cleared Feb 24, 1999

MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE

K984310 · Moss Tubes, Inc.

KNT · Tubes, Gastrointestinal (and Accessories) · 84d

Cleared Feb 24, 1999

K990006 · Ercons, Inc.

LKY · Device, External Penile Rigidity · 51d

Cleared Feb 24, 1999

K990008 · Ercons, Inc.

LKY · Device, External Penile Rigidity · 51d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices