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
153d
Avg (2y)
1976
Since
2339 Gastroenterology & Urology devices
1651–1675 of 2339
Cleared Mar 19, 2008
MEDLINE GASTROSTOMY TUBE
K073718 · Medline Industries, Inc.
KGC · Tube, Gastro-enterostomy · 79d
Cleared Feb 27, 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · Boston Scientific Corp
ESW · Prosthesis, Esophageal · 99d
Cleared Feb 06, 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 505d
Cleared Jan 04, 2008
LITHOSKOP
K070665 · Siemens Medical Solutions USA, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 298d
Cleared Dec 26, 2007
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
K072788 · KARL STORZ Endoscopy-America, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 86d
Cleared Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · Boston Scientific Corporation
KNT · Tubes, Gastrointestinal (and Accessories) · 101d
Cleared Dec 07, 2007
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
K070582 · C.R. Bard, Inc.
EZL · Catheter, Retention Type, Balloon · 281d
Cleared Dec 07, 2007
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS
K070558 · C.R. Bard, Inc.
EZL · Catheter, Retention Type, Balloon · 283d
Cleared Nov 08, 2007
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
K062264 · Medtronic Vascular
FGE · Stents, Drains And Dilators For The Biliary Ducts · 461d
Cleared Nov 01, 2007
MODULARIS VARIOSTAR
K070799 · Siemens Medical Solutions USA, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 223d
Cleared Aug 30, 2007
STORZ SLX-F2 STORM TOUCH
K070579 · KARL STORZ Endoscopy-America, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 182d
Cleared Jul 18, 2007
MEDLINE LATEX FOLEY CATHETER
K071423 · Medline Industries, Inc.
EZL · Catheter, Retention Type, Balloon · 57d
Cleared Jun 29, 2007
SPYCATCH STONE RETRIEVAL BASKET
K071066 · Boston Scientific Corp
LQR · Dislodger, Stone, Biliary · 74d
Cleared May 31, 2007
IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
K070716 · KARL STORZ Endoscopy-America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 78d
Cleared May 22, 2007
KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120
K070827 · KARL STORZ Endoscopy-America, Inc.
ODA · Endoscopic Central Control Unit · 57d
Cleared Apr 24, 2007
BARD MALECOT AND PEZZER DRAINS
K070879 · C.R. Bard, Inc.
FEW · Catheter, Malecot · 25d
Cleared Mar 21, 2007
ALIGN URETHRAL SUPPORT SYSTEM
K070073 · C.R. Bard, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 72d
Cleared Mar 09, 2007
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
K070508 · C.R. Bard, Inc.
EZL · Catheter, Retention Type, Balloon · 15d
Cleared Feb 13, 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 125d
Cleared Jan 31, 2007
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
K063585 · KARL STORZ Endoscopy-America, Inc.
FDF · Colonoscope And Accessories, Flexible/rigid · 61d
Cleared Jan 17, 2007
KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM
K062918 · KARL STORZ Endoscopy-America, Inc.
FBO · Cystourethroscope · 111d
Cleared Jan 05, 2007
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
K063632 · C.R. Bard, Inc.
LJE · Catheter, Nephrostomy · 30d
Cleared Dec 15, 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K063446 · C.R. Bard, Inc.
NFK · Kit, Repair, Catheter, Hemodialysis · 30d
Cleared Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
K062750 · Boston Scientific Corp
MUM · Stent, Metallic, Expandable, Duodenal · 81d
Cleared Nov 09, 2006
KARL STORZ VIDEO GASTROSCOPES
K060907 · KARL STORZ Endoscopy-America, Inc.
FDS · Gastroscope And Accessories, Flexible/rigid · 220d

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All categories 2339 FGE Stents, Drains And Dilators For The Biliary Ducts 155 KNT Tubes, Gastrointestinal (and Accessories) 110 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 74 FGB Ureteroscope And Accessories, Flexible/rigid 70 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 66 PKL Hemostatic Metal Clip For The Gi Tract 49 FED Endoscopic Access Overtube, Gastroenterology-urology 48 ODC Endoscope Channel Accessory 47 FAD Stent, Ureteral 45 FAJ Cystoscope And Accessories, Flexible/rigid 44 OCX Endoscopic Irrigation/suction System 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDS Gastroscope And Accessories, Flexible/rigid 39 FDF Colonoscope And Accessories, Flexible/rigid 39