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
153d
Avg (2y)
1976
Since
2333 Gastroenterology & Urology devices
Cleared
Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
89d
Cleared
Jan 27, 2017
Universa Firm Ureteral Stents and Stent Sets
FAD
Stent, Ureteral
270d
Cleared
Jan 19, 2017
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
78d
Cleared
Jan 06, 2017
Oracle EUS Balloon
FDF
Colonoscope And Accessories, Flexible/rigid
24d
Cleared
Jan 06, 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
MPB
Catheter, Hemodialysis, Non-implanted
219d
Cleared
Nov 29, 2016
Medline ENFit Syringe
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
267d
Cleared
Oct 12, 2016
Express SD Biliary Monorail Premounted Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
44d
Cleared
Jun 17, 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
67d
Cleared
May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
36d
Cleared
Mar 31, 2016
Proxis Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
2d
Cleared
Mar 30, 2016
Rotatable Snares
FDI
Snare, Flexible
23d
Cleared
Feb 04, 2016
Medline Anti-Fog Solution
OCT
Anti Fog Solution And Accessories, Endoscopy
121d
Cleared
Feb 01, 2016
Image1 SPIES System
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
24d
Cleared
Jan 05, 2016
Zenysis Short-Term Dialysis Catheter
MPB
Catheter, Hemodialysis, Non-implanted
63d
Cleared
Dec 11, 2015
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
46d
Cleared
Nov 20, 2015
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
FGE
Stents, Drains And Dilators For The Biliary Ducts
52d
Cleared
Nov 13, 2015
LithoVue System
FGB
Ureteroscope And Accessories, Flexible/rigid
24d
Cleared
Oct 22, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
FCG
Biopsy Needle
104d
Cleared
Oct 06, 2015
AXIOS Stent and Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
27d
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
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