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
2289 Gastroenterology & Urology devices
Cleared
Sep 03, 2020
Delta III Lithotripter
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
134d
Cleared
Sep 02, 2020
SmartHDM-510 System
FIZ
Meter, Conductivity, Non-remote
65d
Cleared
Sep 02, 2020
Endofresh Digestive Endoscopy System
FDS
Gastroscope And Accessories, Flexible/rigid
341d
Cleared
Sep 01, 2020
Image1 S CCU, Image1 S 4U Camera Head
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
126d
Cleared
Sep 01, 2020
Resolution 360™ ULTRA Clip
PKL
Hemostatic Metal Clip For The Gi Tract
266d
Cleared
Aug 28, 2020
Temno Elite Biopsy System
KNW
Instrument, Biopsy
119d
Cleared
Aug 28, 2020
OES Elite Ureteroscopes and Accessories
FGB
Ureteroscope And Accessories, Flexible/rigid
196d
Cleared
Aug 28, 2020
DIMI RRT System
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
305d
Not Cleared
Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
QAX
Hemodialyzer With Expanded Solute Removal Profile
347d
Cleared
Aug 27, 2020
Konix Anti-Fog Solution
OCT
Anti Fog Solution And Accessories, Endoscopy
512d
Cleared
Aug 17, 2020
WallFlex Colonic Stent System with Anchor Lock Delivery System
MQR
Stent, Colonic, Metallic, Expandable
109d
Cleared
Aug 07, 2020
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
KNW
Instrument, Biopsy
91d
Cleared
Aug 03, 2020
Vesco Medical Extension Feeding Set
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
283d
Cleared
Jul 31, 2020
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
PEW
Implantable Transprostatic Tissue Retractor System
29d
Cleared
Jul 31, 2020
Cyber Blade
GCJ
Laparoscope, General & Plastic Surgery
324d
Cleared
Jul 30, 2020
SpeediCath Soft
GBM
Catheter, Urethral
190d
Cleared
Jul 30, 2020
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
197d
Cleared
Jul 24, 2020
Ureterorenoscope System
FGB
Ureteroscope And Accessories, Flexible/rigid
71d
Cleared
Jul 23, 2020
PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
189d
Cleared
Jul 17, 2020
Ambu Duodeno System
FDT
Duodenoscope And Accessories, Flexible/rigid
84d
Cleared
Jul 17, 2020
Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I
FDF
Colonoscope And Accessories, Flexible/rigid
291d
Cleared
Jul 10, 2020
Pelvital System
HIR
Perineometer
142d
Cleared
Jul 09, 2020
ETHICON Linx Esophagus Sizing Tool
QJN
Laparoscopic Accessories, Esophageal Sizing
80d
Cleared
Jul 09, 2020
Optiflux Enexa F500 Dialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
266d
Cleared
Jul 06, 2020
Fujifilm Ultrasonic Processor
FDS
Gastroscope And Accessories, Flexible/rigid
97d
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