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
8412 Gastroenterology & Urology devices
Cleared
Mar 05, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
FPD
Tube, Feeding
76d
Cleared
Mar 04, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
FPD
Tube, Feeding
75d
Cleared
Mar 03, 2009
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
99d
Cleared
Mar 03, 2009
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
EYB
Catheter, Ureteral, Gastro-urology
74d
Cleared
Feb 20, 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
63d
Cleared
Feb 20, 2009
CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
FPD
Tube, Feeding
63d
Cleared
Feb 20, 2009
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Feb 19, 2009
MODIFICATION TO AUTO-BAND LIGATOR
MND
Ligator, Esophageal
79d
Cleared
Feb 12, 2009
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
107d
Cleared
Feb 12, 2009
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
MPB
Catheter, Hemodialysis, Non-implanted
28d
Cleared
Feb 10, 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
MSD
Catheter, Hemodialysis, Implanted
26d
Cleared
Feb 10, 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
FJK
Set, Tubing, Blood, With And Without Anti-regurgitation Valve
8d
Cleared
Feb 06, 2009
SMART DILATOR
KNQ
Dilator, Esophageal
121d
Cleared
Feb 06, 2009
ECHOTIP ULTRA ULTRASOUND NEEDLE
FCG
Biopsy Needle
86d
Cleared
Feb 05, 2009
ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX
KNT
Tubes, Gastrointestinal (and Accessories)
55d
Cleared
Feb 04, 2009
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
KNT
Tubes, Gastrointestinal (and Accessories)
103d
Cleared
Feb 04, 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
ODF
Mini Endoscope, Gastroenterology-urology
12d
Cleared
Feb 03, 2009
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
167d
Cleared
Jan 30, 2009
NITI-S ESOPHAGEAL STENT
ESW
Prosthesis, Esophageal
317d
Cleared
Jan 23, 2009
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
KNT
Tubes, Gastrointestinal (and Accessories)
129d
Cleared
Jan 21, 2009
A.V. FISTULA BLUNT NEEDLE SET
FIE
Needle, Fistula
113d
Cleared
Jan 21, 2009
COSTORSOL
KDN
System, Perfusion, Kidney
61d
Cleared
Jan 14, 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
285d
Cleared
Jan 13, 2009
HD CAMERA HEAD OTV-S7PROH-HD-L08E
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
81d
Cleared
Jan 09, 2009
MEDINOL X-SUIT NIR BILIARY METALLIC STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
184d
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