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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8377 Gastroenterology & Urology devices
Cleared
May 04, 2017
Flex Robotic System and Flex Colorectal Drive
FDF
Colonoscope And Accessories, Flexible/rigid
258d
Cleared
May 04, 2017
Cedic Enteral ENFit Transition Connectors
PIO
Enteral Specific Transition Connectors
267d
Cleared
May 03, 2017
PrisMax Control Unit
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
138d
Cleared
May 03, 2017
Asahi ViE-U Series Dialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
266d
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 18, 2017
EndoRotor
PTE
Endoscopic Morcellator Gastroenterology
95d
Cleared
Apr 17, 2017
EndoFLIP® System with FLIP Topography module
FFX
System, Gastrointestinal Motility (electrical)
28d
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 30, 2017
Hach CM130 Chlorine Monitoring System
PSX
Chlorine Meter
205d
Cleared
Mar 29, 2017
Brevera Biopsy System with Corlumina Imaging Technology
KNW
Instrument, Biopsy
148d
Cleared
Mar 24, 2017
Veloxion System
FJL
Resectoscope
149d
Cleared
Mar 22, 2017
ENFit enteral syringe
PNR
Enteral Syringes With Enteral Specific Connectors
247d
Cleared
Mar 22, 2017
ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
PNR
Enteral Syringes With Enteral Specific Connectors
334d
Cleared
Mar 20, 2017
Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
KNW
Instrument, Biopsy
25d
Cleared
Mar 17, 2017
Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
87d
Cleared
Mar 14, 2017
THD ANOPRESS
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
258d
Cleared
Mar 14, 2017
Rapid Barostat Bag (RBB) Pump and Catheter
FFX
System, Gastrointestinal Motility (electrical)
405d
Cleared
Mar 10, 2017
AdvanCE capsule endoscope delivery device
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
87d
Cleared
Mar 07, 2017
Flexi-Seal PROTECT Fecal Management System
KNT
Tubes, Gastrointestinal (and Accessories)
141d
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