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
Cleared
Jul 07, 2008
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
KOC
Accessories, Blood Circuit, Hemodialysis
84d
Cleared
Jun 13, 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
175d
Cleared
Jun 12, 2008
ETHICON ENDO SURGERY ARTICULATING SNARE
FDI
Snare, Flexible
204d
Cleared
May 30, 2008
BARD E LUMINEXX BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
555d
Cleared
May 20, 2008
XTJF TYPE Q160VF1
FDT
Duodenoscope And Accessories, Flexible/rigid
96d
Cleared
May 13, 2008
GRADUATED ADAPTER WITH CLAVE
EZD
Catheter, Straight
132d
Cleared
May 13, 2008
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT
MSD
Catheter, Hemodialysis, Implanted
90d
Cleared
May 09, 2008
EVOLUTION ESOPHAGEAL STENT SYSTEM
ESW
Prosthesis, Esophageal
88d
Cleared
May 06, 2008
OLYMPUS XCHF TYPE B180Y1
FBN
Choledochoscope And Accessories, Flexible/rigid
64d
Cleared
May 06, 2008
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
54d
Cleared
Apr 09, 2008
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
ODA
Endoscopic Central Control Unit
55d
Cleared
Mar 25, 2008
SMALL INTESTINAL VIDEOSCOPE SYSTEM
FDA
Enteroscope And Accessories
326d
Cleared
Mar 19, 2008
MEDLINE GASTROSTOMY TUBE
KGC
Tube, Gastro-enterostomy
79d
Cleared
Mar 18, 2008
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
FGE
Stents, Drains And Dilators For The Biliary Ducts
214d
Cleared
Mar 18, 2008
EVIS EXERA II 180 SYSTEM
NWB
Endoscope, Accessories, Narrow Band Spectrum
151d
Cleared
Mar 10, 2008
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431
ODC
Endoscope Channel Accessory
90d
Cleared
Feb 27, 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
ESW
Prosthesis, Esophageal
99d
Cleared
Feb 26, 2008
KIMBERLY-CLARK INTRODUCER KITS
KGC
Tube, Gastro-enterostomy
26d
Cleared
Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
FIB
Protector, Transducer, Dialysis
121d
Cleared
Feb 06, 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
FGE
Stents, Drains And Dilators For The Biliary Ducts
505d
Cleared
Jan 30, 2008
AMS MINIARC SLING SYSTEM
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
30d
Cleared
Jan 04, 2008
LITHOSKOP
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
298d
Cleared
Dec 26, 2007
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
86d
Cleared
Dec 18, 2007
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
FAJ
Cystoscope And Accessories, Flexible/rigid
134d
Cleared
Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
KNT
Tubes, Gastrointestinal (and Accessories)
101d
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