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
2647 Gastroenterology & Urology devices
Cleared
Mar 11, 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
MSF
Hemodialyzer, Re-use, High Flux
383d
Cleared
Feb 09, 1998
MODIFIED URETERAL INDWELLING CATHETER/STENT
FAD
Stent, Ureteral
68d
Cleared
Jan 30, 1998
CAPIOX HEMOCONCENTRATOR
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
135d
Cleared
Jan 28, 1998
PUBOUURETHRAL SLING
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
90d
Cleared
Jan 21, 1998
MICROVASIVE LIPTHOTRIPSY PROBES
FFK
Lithotriptor, Electro-hydraulic
107d
Cleared
Jan 11, 1998
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
MSF
Hemodialyzer, Re-use, High Flux
324d
Cleared
Dec 19, 1997
CLIRANS T-SERIES HOLLOW FIBER DIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
296d
Cleared
Dec 15, 1997
COURIER ST BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
124d
Cleared
Dec 11, 1997
SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM
FBO
Cystourethroscope
122d
Cleared
Dec 11, 1997
MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
KNX
Collector, Urine, (and Accessories) For Indwelling Catheter
128d
Cleared
Dec 05, 1997
SPHINCTEROTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
59d
Cleared
Dec 01, 1997
THE AUTO SUTURE* MIBB** SYSTEM
KNW
Instrument, Biopsy
77d
Cleared
Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
FJI
Dialyzer, Capillary, Hollow Fiber
419d
Cleared
Nov 12, 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
MSE
Hemodialyzer, Re-use, Low Flux
264d
Cleared
Nov 12, 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
MSE
Hemodialyzer, Re-use, Low Flux
264d
Cleared
Nov 10, 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
82d
Cleared
Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
494d
Cleared
Nov 03, 1997
QUICK-CARE BIOPSY NEEDLE
KNW
Instrument, Biopsy
45d
Cleared
Oct 30, 1997
HX-20/21-1 ENDOSCOPIC LIGATOR
MND
Ligator, Esophageal
344d
Cleared
Oct 27, 1997
COMBIPORT FLUID LAVAGE DEVICE
KDH
Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
206d
Cleared
Oct 16, 1997
BARD ENDOSCOPIC OVERTUBE (#000307)
FED
Endoscopic Access Overtube, Gastroenterology-urology
30d
Cleared
Oct 16, 1997
BARD RAPIDFIRE MULTIPLE BAND LIGATOR
MND
Ligator, Esophageal
202d
Cleared
Oct 09, 1997
CRE BALLOON DILATATION CATHETER
KNQ
Dilator, Esophageal
182d
Cleared
Oct 08, 1997
MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE
FBN
Choledochoscope And Accessories, Flexible/rigid
61d
Cleared
Oct 07, 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
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