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
2599 Gastroenterology & Urology devices
Cleared
Oct 06, 2015
AXIOS Stent and Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
27d
Cleared
Sep 30, 2015
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Aug 07, 2015
Corvocet Coaxial Introducer
FCG
Biopsy Needle
78d
Cleared
Aug 06, 2015
Resolution Clip
PKL
Hemostatic Metal Clip For The Gi Tract
35d
Cleared
Aug 05, 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
140d
Cleared
Jul 28, 2015
Bard LubriGuard Foley Catheter
EZL
Catheter, Retention Type, Balloon
132d
Cleared
Jul 24, 2015
Medline ENFit Connectors
PIO
Enteral Specific Transition Connectors
37d
Cleared
Jun 01, 2015
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
357d
Cleared
May 29, 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
73d
Cleared
May 11, 2015
Magic3 Go Intermittent Urinary Catheter
EZD
Catheter, Straight
89d
Cleared
Apr 27, 2015
Medline Enteral Feeding Sets
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
81d
Cleared
Jan 16, 2015
SpyGlass DS Direct Visualization System
FBN
Choledochoscope And Accessories, Flexible/rigid
100d
Cleared
Jan 09, 2015
Medline Silicone Foley Catheter
EZL
Catheter, Retention Type, Balloon
114d
Cleared
Dec 01, 2014
Resolution Clip
PKL
Hemostatic Metal Clip For The Gi Tract
48d
Cleared
Nov 26, 2014
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
182d
Cleared
Nov 18, 2014
UNIVERSA PERCULTANEOUS DRAINAGE CATHETER
FEW
Catheter, Malecot
309d
Cleared
Oct 31, 2014
Bard RiteCath Intermittent Urinary Catheter
EZD
Catheter, Straight
49d
Cleared
Oct 23, 2014
Flexible Video-Uretero-Choledochoscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
42d
Cleared
Oct 21, 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
106d
Cleared
Oct 17, 2014
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
FAD
Stent, Ureteral
148d
Cleared
Oct 17, 2014
EXPEL APD DRAINAGE CATHETER SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
149d
Cleared
Sep 24, 2014
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
316d
Cleared
Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
70d
Cleared
Jul 21, 2014
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
FDI
Snare, Flexible
119d
Cleared
Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
275d
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