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
9843
Total
9796
Cleared
154d
Avg (2y)
1976
Since
2605 Gastroenterology & Urology devices
Cleared
Jan 25, 2013
POWER LED 175
FCW
Light Source, Fiberoptic, Routine
35d
Cleared
Dec 12, 2012
NAVIGATOR HD URETERAL ACCESS SHEATH SET
FED
Endoscopic Access Overtube, Gastroenterology-urology
104d
Cleared
Dec 03, 2012
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
PKL
Hemostatic Metal Clip For The Gi Tract
94d
Cleared
Nov 02, 2012
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
24d
Cleared
Oct 24, 2012
CRE FIXED WIRE BALLON DILATION CATHETER
KNQ
Dilator, Esophageal
30d
Cleared
Oct 10, 2012
BLUE SUI SLING
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
118d
Cleared
Sep 28, 2012
WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
FGE
Stents, Drains And Dilators For The Biliary Ducts
74d
Cleared
Sep 20, 2012
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
FCW
Light Source, Fiberoptic, Routine
100d
Cleared
Sep 18, 2012
NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
LJE
Catheter, Nephrostomy
109d
Cleared
Aug 17, 2012
TRUETOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
23d
Cleared
Jul 17, 2012
RESOLVE BILIARY LOCKING DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
25d
Cleared
Jun 12, 2012
MODULTH SLK
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
90d
Cleared
May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ESW
Prosthesis, Esophageal
30d
Cleared
Apr 20, 2012
SAFETY SCREW CONNECTOR
KNT
Tubes, Gastrointestinal (and Accessories)
123d
Cleared
Apr 06, 2012
IMAGE1 GI CCU MODEL 22203020-114
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
268d
Cleared
Feb 10, 2012
CRE DITATATION BALLON
FGE
Stents, Drains And Dilators For The Biliary Ducts
126d
Cleared
Jan 06, 2012
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
ODA
Endoscopic Central Control Unit
255d
Cleared
Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
119d
Cleared
Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
ODG
Endoscopic Ultrasound System, Gastroenterology-urology
44d
Cleared
Aug 26, 2011
COMFORTGLIDE INTERMITENT CATHETER
EZD
Catheter, Straight
31d
Cleared
Jul 29, 2011
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
ESW
Prosthesis, Esophageal
50d
Cleared
Jun 16, 2011
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
KNW
Instrument, Biopsy
57d
Cleared
May 06, 2011
ASPIRA PERITONEAL DRAINAGE SYSTEM
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
84d
Cleared
Apr 20, 2011
CRE BALLOON DILATATION CATHETER
FDT
Duodenoscope And Accessories, Flexible/rigid
26d
Cleared
Apr 14, 2011
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
15d
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