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
5367 Gastroenterology & Urology devices
Cleared
Jan 11, 2016
Universa Soft Ureteral Stents and Stent Sets
FAD
Stent, Ureteral
266d
Cleared
Jan 05, 2016
Zenysis Short-Term Dialysis Catheter
MPB
Catheter, Hemodialysis, Non-implanted
63d
Cleared
Dec 16, 2015
AquaShield system CO2, AquaShield system-PENTAX
FEQ
Pump, Air, Non-manual, For Endoscope
26d
Cleared
Dec 15, 2015
Balloon controller PB-30
FDF
Colonoscope And Accessories, Flexible/rigid
12d
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
Dec 10, 2015
Fuse Gastroscopy System
FDS
Gastroscope And Accessories, Flexible/rigid
127d
Cleared
Dec 10, 2015
Sterile Repositionable Hemostasis Clipping Device
PKL
Hemostatic Metal Clip For The Gi Tract
143d
Cleared
Dec 10, 2015
2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
266d
Cleared
Nov 24, 2015
OES ELITE Telescopes, Protective Tube
FBP
Telescope, Rigid, Endoscopic
204d
Cleared
Nov 24, 2015
PENTAX Medical EPK-i7010 Video Processor with GI Family
PEA
Endoscope, Accessories, Image Post-processing For Color Enhancement
259d
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 20, 2015
Single Use Aspiration Needle NA-U200H
FCG
Biopsy Needle
147d
Cleared
Nov 13, 2015
LithoVue System
FGB
Ureteroscope And Accessories, Flexible/rigid
24d
Cleared
Nov 06, 2015
Elation Wireguided Balloon Dilation Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
116d
Cleared
Nov 05, 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
KOC
Accessories, Blood Circuit, Hemodialysis
29d
Cleared
Nov 03, 2015
rescuenet
FDI
Snare, Flexible
54d
Cleared
Oct 29, 2015
Optiflux dialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
69d
Cleared
Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
90d
Cleared
Oct 27, 2015
Express SD Biliary Monorail Premounted Stent System
FGE
Stents, Drains And Dilators For The Biliary Ducts
46d
Cleared
Oct 26, 2015
Resection Electrodes
FAS
Electrode, Electrosurgical, Active, Urological
90d
Cleared
Oct 22, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
FCG
Biopsy Needle
104d
Cleared
Oct 16, 2015
Disposable Multistage Dilation Balloon Catheter
FGE
Stents, Drains And Dilators For The Biliary Ducts
116d
Cleared
Oct 15, 2015
iSnare system-Lariat
FBK
Endoscopic Injection Needle, Gastroenterology-urology
85d
Cleared
Oct 08, 2015
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
203d
Cleared
Oct 08, 2015
Single Use Balloon Dilator V (with Knife)
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
259d
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