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
5367 Gastroenterology & Urology devices
1976–2000 of 5367
Cleared Nov 20, 2009
ENCOR BREAST BIOPSY SYSTEM
K093512 · Senorx, Inc.
KNW · Instrument, Biopsy · 7d
Cleared Nov 20, 2009
AJUST ADJUSTABLE SINGLE INCISION SLING
K092607 · C.R. Bard, Inc.
PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling · 87d
Cleared Nov 10, 2009
ETHICON ENDO-SURGERYOPTICAL DILATOR
K093236 · Ethicon Endo-Surgery, Inc.
KNQ · Dilator, Esophageal · 26d
Cleared Nov 10, 2009
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US
K093068 · C.R. Bard, Inc.
KNW · Instrument, Biopsy · 41d
Cleared Nov 05, 2009
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140
K092461 · United States Endoscopy Group, Inc.
OCX · Endoscopic Irrigation/suction System · 86d
Cleared Nov 02, 2009
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
K092359 · Cook Ireland, Ltd.
FCG · Biopsy Needle · 90d
Cleared Oct 30, 2009
SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
K092309 · Olympus Medical Systems Corporation
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 92d
Cleared Oct 20, 2009
COLONIC SPLINTING OVERTUBE, MODEL 00711145
K092221 · United States Endoscopy Group, Inc.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 90d
Cleared Oct 09, 2009
3 WAY SILICONE FOLEY BALLOON CATHETER
K091767 · Cook Urological, Inc.
EZL · Catheter, Retention Type, Balloon · 114d
Cleared Sep 30, 2009
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER
K091962 · Lumenis, Inc.
ODF · Mini Endoscope, Gastroenterology-urology · 91d
Cleared Sep 28, 2009
GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
K090557 · Given Imaging , Ltd.
NSI · System, Imaging, Esophageal, Wireless, Capsule · 210d
Cleared Sep 24, 2009
RP CUTTING NEEDLE
K092059 · Riverpoint Medical
KNW · Instrument, Biopsy · 79d
Cleared Sep 18, 2009
SINGLE USE SPLINTING TUBE, MODELS ST-Y0002-S, ST-Y0002-H, ST-Y0003-S AND ST-Y0003-H
K091759 · Olympus Medical Systems Corporation
KNT · Tubes, Gastrointestinal (and Accessories) · 94d
Cleared Sep 14, 2009
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968 · KARL STORZ Endoscopy-America, Inc.
FCW · Light Source, Fiberoptic, Routine · 75d
Cleared Sep 03, 2009
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A
K091495 · Olympus Medical Systems Corporation
LQR · Dislodger, Stone, Biliary · 106d
Cleared Aug 21, 2009
AMSURE PVC INTERMITTENT CATHETER
K091306 · Amsino International, Inc.
EZD · Catheter, Straight · 109d
Cleared Aug 20, 2009
VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064, 72084, 72104, 72124,72144, 72164, 72184,
K090960 · Hollister, Inc.
GBM · Catheter, Urethral · 136d
Cleared Aug 10, 2009
AMSURE HYDROPHILIC LATEX FOLEY CATHETER
K091699 · Amsino International, Inc.
EZL · Catheter, Retention Type, Balloon · 61d
Cleared Aug 07, 2009
FUJINON STERILE OVERTUBES
K091773 · Fujinon, Inc.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 52d
Cleared Aug 07, 2009
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A
K090002 · Baxter Healthcare Corp
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 217d
Cleared Jul 29, 2009
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
K091405 · Given Imaging , Ltd.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 78d
Cleared Jul 29, 2009
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210 · Olympus Medical Systems Corporation
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 182d
Cleared Jul 10, 2009
COOK UROLOGICAL GRAFT
K090688 · Cook Biotech, Inc.
PAG · Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 116d
Cleared Jul 01, 2009
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · Boston Scientific Corporation
ESW · Prosthesis, Esophageal · 13d
Cleared Jun 29, 2009
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
K090980 · Olympus Winter & Ibe GmbH
NWB · Endoscope, Accessories, Narrow Band Spectrum · 83d

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All categories 5367 FGE Stents, Drains And Dilators For The Biliary Ducts 314 KNT Tubes, Gastrointestinal (and Accessories) 301 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 217 KOD Catheter, Urological 128 KNW Instrument, Biopsy 122 KOC Accessories, Blood Circuit, Hemodialysis 121 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 116 FJI Dialyzer, Capillary, Hollow Fiber 96 FAD Stent, Ureteral 94 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 91 FGB Ureteroscope And Accessories, Flexible/rigid 89 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 81 FDF Colonoscope And Accessories, Flexible/rigid 71 EXB Collector, Ostomy 68 FED Endoscopic Access Overtube, Gastroenterology-urology 67