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
5366 Gastroenterology & Urology devices
Cleared
May 04, 2017
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered
MUM
Stent, Metallic, Expandable, Duodenal
143d
Cleared
May 03, 2017
PrisMax Control Unit
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
138d
Cleared
Apr 27, 2017
Accessory Irrigation Adapter
ODC
Endoscope Channel Accessory
269d
Cleared
Apr 25, 2017
Processor VP-7000, Light Source BL-7000
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
119d
Cleared
Apr 24, 2017
C-Flex Ureteral Stent Set
FAD
Stent, Ureteral
269d
Cleared
Apr 13, 2017
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
224d
Cleared
Apr 06, 2017
Optiflux dialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
211d
Cleared
Apr 06, 2017
Howell Biliary Aspiration Needle
FCK
Instrument, Biopsy, Suction
463d
Cleared
Apr 04, 2017
Zenysis Short-Term Dialysis Catheter
MPB
Catheter, Hemodialysis, Non-implanted
116d
Cleared
Mar 30, 2017
AngioDynamics Total Abscession Biliary Drainage Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
20d
Cleared
Mar 29, 2017
Brevera Biopsy System with Corlumina Imaging Technology
KNW
Instrument, Biopsy
148d
Cleared
Mar 10, 2017
AdvanCE capsule endoscope delivery device
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
87d
Cleared
Feb 28, 2017
Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set
KNW
Instrument, Biopsy
56d
Cleared
Feb 24, 2017
Rusch Simplastic Foley Catheters
EZL
Catheter, Retention Type, Balloon
120d
Cleared
Feb 18, 2017
AXIOS Stent and Electrocautery Enhanced Delivery System
PCU
Pancreatic Stent, Covered, Metallic, Removable
89d
Cleared
Feb 08, 2017
FB-U Hemodialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
357d
Cleared
Feb 07, 2017
Zilver 518TM Biliary Stent
FGE
Stents, Drains And Dilators For The Biliary Ducts
85d
Cleared
Jan 30, 2017
Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
90d
Cleared
Jan 27, 2017
Universa Firm Ureteral Stents and Stent Sets
FAD
Stent, Ureteral
270d
Cleared
Jan 25, 2017
Reliant Multistage Dilatation Balloon Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
170d
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
PrismaSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
81d
Cleared
Jan 06, 2017
Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray
MPB
Catheter, Hemodialysis, Non-implanted
219d
Cleared
Jan 06, 2017
SureClip(TM) Repositionable Hemostasis Clip
PKL
Hemostatic Metal Clip For The Gi Tract
225d
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