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
8381 Gastroenterology & Urology devices
Cleared
Jan 20, 2016
Firefly Peritoneal Dialysis Connector Disinfection System
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
218d
Cleared
Jan 15, 2016
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
FDT
Duodenoscope And Accessories, Flexible/rigid
438d
Cleared
Jan 14, 2016
Spectra Optia Apheresis System
LKN
Separator, Automated, Blood Cell And Plasma, Therapeutic
29d
Cleared
Jan 14, 2016
PillCam COLON 2 Capsule Endoscopy System
PGD
Colon Capsule Imaging System
44d
Cleared
Jan 12, 2016
core nova Complete Operating Room Endoscopy
ODA
Endoscopic Central Control Unit
243d
Cleared
Jan 11, 2016
Universa Soft Ureteral Stents and Stent Sets
FAD
Stent, Ureteral
266d
Cleared
Jan 07, 2016
Well Lead Ureteral Access Sheath
FED
Endoscopic Access Overtube, Gastroenterology-urology
260d
Cleared
Jan 05, 2016
Zenysis Short-Term Dialysis Catheter
MPB
Catheter, Hemodialysis, Non-implanted
63d
Cleared
Jan 05, 2016
K2M Fenestrated Tap System
KNW
Instrument, Biopsy
97d
Cleared
Dec 22, 2015
New Medax Biopsy Systems
KNW
Instrument, Biopsy
505d
Cleared
Dec 18, 2015
Imbibe Needle
KNW
Instrument, Biopsy
32d
Cleared
Dec 17, 2015
Asahi REXEED-S Series Dialyzer
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
28d
Cleared
Dec 17, 2015
NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps
PNR
Enteral Syringes With Enteral Specific Connectors
78d
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
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
KNT
Tubes, Gastrointestinal (and Accessories)
10d
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
Dec 04, 2015
HMB32
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
235d
Cleared
Dec 03, 2015
Disposable Endoscope Valves Set A
ODC
Endoscope Channel Accessory
161d
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 24, 2015
SilverCoat Silicone Foley Catheter
EZL
Catheter, Retention Type, Balloon
266d
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