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
8406 Gastroenterology & Urology devices
Cleared
May 22, 2009
BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
FED
Endoscopic Access Overtube, Gastroenterology-urology
256d
Cleared
May 22, 2009
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
OCY
Endoscopic Guidewire, Gastroenterology-urology
9d
Cleared
May 19, 2009
MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
FFX
System, Gastrointestinal Motility (electrical)
35d
Cleared
May 18, 2009
VS-100 ILLUMINATION AND IMAGING SYSTEM
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
55d
Cleared
May 15, 2009
BACKSTOP CATHETER, MODEL 60-0000-3100
KOD
Catheter, Urological
100d
Cleared
May 12, 2009
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
MNW
Analyzer, Body Composition
140d
Cleared
May 11, 2009
FSC 2
NTN
Led Light Source
67d
Cleared
May 08, 2009
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
MSY
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
87d
Cleared
May 08, 2009
MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
FCG
Biopsy Needle
9d
Cleared
May 07, 2009
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
OTM
Mesh, Surgical, For Stress Urinary Incontinence, Male
17d
Cleared
May 04, 2009
FOOTPRINT MEDICAL SILICONE FEEDING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
63d
Cleared
Apr 23, 2009
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
FBK
Endoscopic Injection Needle, Gastroenterology-urology
84d
Cleared
Apr 22, 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
160d
Cleared
Apr 22, 2009
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
FDF
Colonoscope And Accessories, Flexible/rigid
91d
Cleared
Apr 20, 2009
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
FAJ
Cystoscope And Accessories, Flexible/rigid
26d
Cleared
Apr 15, 2009
PRE-FILLED CATHETER INFLATION SYRINGE
KNY
Accessories, Catheter, G-u
84d
Cleared
Apr 13, 2009
PROGUIDE CHRONIC DIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
82d
Cleared
Apr 09, 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
FAE
Prosthesis, Penile
28d
Cleared
Apr 07, 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
FGE
Stents, Drains And Dilators For The Biliary Ducts
120d
Cleared
Mar 30, 2009
NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
KOC
Accessories, Blood Circuit, Hemodialysis
194d
Cleared
Mar 20, 2009
BODYMETRIX BX2000
OMV
Ultrasonic Body Composition Analyzer
233d
Cleared
Mar 20, 2009
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
FCG
Biopsy Needle
88d
Cleared
Mar 19, 2009
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
98d
Cleared
Mar 12, 2009
HEMOBAND, MODELS HB-NS AND HB-NSXL
KOC
Accessories, Blood Circuit, Hemodialysis
266d
Cleared
Mar 09, 2009
SILS STITCH ENDOSCOPIC SUTURING DEVICE
OCW
Endoscopic Tissue Approximation Device
19d
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