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
2617 Gastroenterology & Urology devices
1676–1700 of 2617
Cleared Jun 13, 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 175d
Cleared Apr 09, 2008
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
K080410 · KARL STORZ Endoscopy-America, Inc.
ODA · Endoscopic Central Control Unit · 55d
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 14, 2007
RESOLVE BILIARY DRAINAGE CATHETER
K063733 · Merit Medical Systems, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 331d
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 22, 2007
S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES
K062720 · Richard Wolf Medical Instruments Corp.
FJL · Resectoscope · 191d
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

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All categories 2617 FGE Stents, Drains And Dilators For The Biliary Ducts 186 KNT Tubes, Gastrointestinal (and Accessories) 125 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 78 FGB Ureteroscope And Accessories, Flexible/rigid 74 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 70 PKL Hemostatic Metal Clip For The Gi Tract 50 FED Endoscopic Access Overtube, Gastroenterology-urology 48 FAD Stent, Ureteral 47 ODC Endoscope Channel Accessory 47 FAJ Cystoscope And Accessories, Flexible/rigid 47 OCX Endoscopic Irrigation/suction System 44 KNW Instrument, Biopsy 43 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDS Gastroscope And Accessories, Flexible/rigid 40