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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5364 Gastroenterology & Urology devices
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
Cleared
Jul 02, 2020
SherpaPak Pediatric Liver Transport System
KDN
System, Perfusion, Kidney
72d
Cleared
Jun 26, 2020
EndoGI Biliary Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
186d
Cleared
Jun 24, 2020
Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve
ODC
Endoscope Channel Accessory
117d
Cleared
Jun 23, 2020
CO2mbiLED
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
60d
Cleared
Jun 23, 2020
Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
106d
Cleared
Jun 22, 2020
GlidePath 10F Long-Term Dialysis Catheter
MSD
Catheter, Hemodialysis, Implanted
104d
Cleared
Jun 20, 2020
EverLift Submucosal Lifting Agent
PLL
Submucosal Injection Agent
338d
Cleared
Jun 18, 2020
Andorate Biopsy Valve, Andorate Biopsy Irrigator
ODC
Endoscope Channel Accessory
112d
Cleared
Jun 17, 2020
Entuit Nasal Jejunal Feeding Tube
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
Jun 11, 2020
In-Ka Ureteral Balloon Dilatation Catheter
EZN
Dilator, Catheter, Ureteral
55d
Cleared
Jun 05, 2020
UroLift Advanced Tissue Control (ATC) System
PEW
Implantable Transprostatic Tissue Retractor System
102d
Cleared
Jun 02, 2020
gastroduodenal FTRD Set
PKL
Hemostatic Metal Clip For The Gi Tract
78d
Cleared
Jun 01, 2020
Jimushi Sterile Urethral Catheter for single use
GBM
Catheter, Urethral
132d
Cleared
May 22, 2020
Kalera Vacuum Aspiration Catheter (K-VAC)
FED
Endoscopic Access Overtube, Gastroenterology-urology
92d
Not Cleared
May 22, 2020
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
QKZ
Magnetically Maneuvered Capsule Endoscopy System
283d
Cleared
May 21, 2020
IntraMarX 3D Radiopaque Marker
FFX
System, Gastrointestinal Motility (electrical)
27d
Cleared
May 21, 2020
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
267d
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