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
5369 Gastroenterology & Urology devices
Cleared
Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
76d
Cleared
Nov 14, 2005
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
FBN
Choledochoscope And Accessories, Flexible/rigid
125d
Cleared
Nov 09, 2005
B. BRAUN MODIFIED BICARBONATE DIALYSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
70d
Cleared
Nov 01, 2005
MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
KNW
Instrument, Biopsy
29d
Cleared
Oct 31, 2005
DSNARE, MODEL 00711087
FCK
Instrument, Biopsy, Suction
133d
Cleared
Oct 28, 2005
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
OCZ
Endoscopic Grasping/cutting Instrument, Non-powered
164d
Cleared
Oct 13, 2005
EVIS EXERA 160A SYSTEM
NWB
Endoscope, Accessories, Narrow Band Spectrum
115d
Cleared
Oct 12, 2005
ENTERAL FEEDING TUBE
BSS
Tube, Nasogastric
131d
Cleared
Oct 11, 2005
COOK IRELAND ECHOBRUSH
FDX
Endoscopic Cytology Brush
50d
Cleared
Oct 05, 2005
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
FAJ
Cystoscope And Accessories, Flexible/rigid
152d
Cleared
Aug 25, 2005
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
Cleared
Aug 24, 2005
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
19d
Cleared
Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
ODF
Mini Endoscope, Gastroenterology-urology
13d
Cleared
Aug 23, 2005
FORMULA 418 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
53d
Cleared
Aug 15, 2005
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3
ODA
Endoscopic Central Control Unit
59d
Cleared
Aug 12, 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
MSD
Catheter, Hemodialysis, Implanted
44d
Cleared
Aug 05, 2005
OMNI SPHINCTEROTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
7d
Cleared
Jul 20, 2005
REPROCESSED COLD BIOPSY FORCEPS
NON
Forceps, Biopsy, Non-electric, Reprocessed
295d
Cleared
Jul 20, 2005
REPROCESSED HOT BIOPSY FORCEPS
NLU
Forceps, Biopsy, Electric, Reprocessed
180d
Cleared
Jul 18, 2005
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
LJE
Catheter, Nephrostomy
59d
Cleared
Jul 14, 2005
CONMED IRRIGATION NOZZLE
KPL
Colonic Irrigation System
86d
Cleared
Jul 12, 2005
ZILVER 635 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
70d
Cleared
Jul 08, 2005
SINGLE USE BALLOON DILATOR MAXPASSTM
FGE
Stents, Drains And Dilators For The Biliary Ducts
130d
Cleared
Jul 08, 2005
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
29d
Cleared
Jun 28, 2005
AMSURE 100% SILICONE FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
63d
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