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
8384 Gastroenterology & Urology devices
Cleared
Jan 14, 2015
AbbVie NJ
KNT
Tubes, Gastrointestinal (and Accessories)
110d
Cleared
Jan 12, 2015
TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
FIN
Tank, Holding, Dialysis
271d
Cleared
Jan 09, 2015
VaPro Pocket
GBM
Catheter, Urethral
22d
Cleared
Jan 09, 2015
Medline Silicone Foley Catheter
EZL
Catheter, Retention Type, Balloon
114d
Cleared
Jan 08, 2015
EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
121d
Cleared
Jan 08, 2015
Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
143d
Cleared
Jan 08, 2015
BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE
PIF
Gastrointestinal Tubes With Enteral Specific Connectors
161d
Cleared
Dec 29, 2014
AQUARIUS Gastrostomy Replacement Tube
KNT
Tubes, Gastrointestinal (and Accessories)
34d
Cleared
Dec 23, 2014
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)
FIE
Needle, Fistula
103d
Cleared
Dec 19, 2014
Echotip Procore HD Ultrasound Biopsy Needle
FCG
Biopsy Needle
88d
Cleared
Dec 19, 2014
TurboSEAL Nasogastric Aspiration Tube
BSS
Tube, Nasogastric
106d
Cleared
Dec 19, 2014
CytoSure Urinary Access System
FAJ
Cystoscope And Accessories, Flexible/rigid
130d
Cleared
Dec 19, 2014
NXSTAGE SYSTEM ONE
ODN
Ultrafiltration-controlled Nocturnal Dialysate Delivery System
172d
Cleared
Dec 18, 2014
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
OCX
Endoscopic Irrigation/suction System
43d
Cleared
Dec 18, 2014
VIBRANCE KEGEL DEVICE (VKD)
HIR
Perineometer
157d
Cleared
Dec 17, 2014
The OnControl Bone Marrow Biopsy System by Vidacare
KNW
Instrument, Biopsy
113d
Cleared
Dec 17, 2014
GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
316d
Cleared
Dec 15, 2014
Intact Advance and Intact Excision XL, Intact BLES
KNW
Instrument, Biopsy
103d
Cleared
Dec 15, 2014
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
272d
Cleared
Dec 10, 2014
AMERIWATER OZONE DISINFECTION SYSTEM
FIN
Tank, Holding, Dialysis
212d
Cleared
Dec 01, 2014
Resolution Clip
PKL
Hemostatic Metal Clip For The Gi Tract
48d
Cleared
Dec 01, 2014
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
FIP
Subsystem, Water Purification
105d
Cleared
Nov 26, 2014
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
182d
Cleared
Nov 26, 2014
APEX
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
205d
Cleared
Nov 26, 2014
SYMETREX LONG TERM HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
233d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices