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
8400 Gastroenterology & Urology devices
Cleared
Oct 20, 2010
GYRUS ACMI BIOCOAG PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
425d
Cleared
Oct 20, 2010
DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
MSD
Catheter, Hemodialysis, Implanted
111d
Cleared
Oct 18, 2010
RE-TRACE URETERAL ACCESS SHEATH
FED
Endoscopic Access Overtube, Gastroenterology-urology
49d
Cleared
Oct 08, 2010
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
78d
Cleared
Oct 05, 2010
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
291d
Cleared
Oct 05, 2010
RADIAL 4 HOT BIOPSY FORCEPS BOX 5
KGE
Forceps, Biopsy, Electric
116d
Cleared
Oct 01, 2010
PERFADEX AND PERFADEX WITH THAM
KDN
System, Perfusion, Kidney
456d
Cleared
Sep 30, 2010
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
154d
Cleared
Sep 13, 2010
OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
FEQ
Pump, Air, Non-manual, For Endoscope
166d
Cleared
Sep 13, 2010
AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
74d
Cleared
Sep 07, 2010
MERIT BIPOLAR COAGULATION PROBE
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
27d
Cleared
Aug 30, 2010
CYSTOSCOPE, MODELS CE0004-C, CE006-C, CE3004-C, CE3027-C, CE7004-C, CE1204-C, CE1227-C
FAJ
Cystoscope And Accessories, Flexible/rigid
270d
Cleared
Aug 30, 2010
CYBERWAND LITHOTRIPTER
FFK
Lithotriptor, Electro-hydraulic
28d
Cleared
Aug 27, 2010
GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER,
KNT
Tubes, Gastrointestinal (and Accessories)
120d
Cleared
Aug 27, 2010
BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENT
KNW
Instrument, Biopsy
57d
Cleared
Aug 23, 2010
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Aug 17, 2010
LO-50 LED LIGHT SOURCE
NTN
Led Light Source
15d
Cleared
Aug 13, 2010
2008 HEMODIALYSIS SORBENT SYSTEM
FKT
System, Dialysate Delivery, Sorbent Regenerated
289d
Cleared
Aug 05, 2010
ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
87d
Cleared
Aug 03, 2010
NEOMED ENTERAL ONLY EXTENSION SET
KNT
Tubes, Gastrointestinal (and Accessories)
183d
Cleared
Aug 03, 2010
COLONOSCOPE/SIGMOIDOSCOPE SHEATHES
FDF
Colonoscope And Accessories, Flexible/rigid
117d
Cleared
Aug 02, 2010
TOUCHSOFT COAGULATOR WITH BANANA FITTING, MODEL 4581 AND WITH UNIVERSAL FITTING, MODEL 4581-U
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
306d
Cleared
Jul 29, 2010
GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
FIP
Subsystem, Water Purification
251d
Cleared
Jul 29, 2010
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
85d
Cleared
Jul 27, 2010
NAVIAID ICVI DEVICE
FDF
Colonoscope And Accessories, Flexible/rigid
90d
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