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
2622 Gastroenterology & Urology devices
Cleared
Jun 16, 2005
SPYSCOPE ACCESS AND DELIVERY CATHETER
FED
Endoscopic Access Overtube, Gastroenterology-urology
9d
Cleared
Jun 16, 2005
EASY CORE DETACHABLE BIOPSY SYSTEM
KNW
Instrument, Biopsy
22d
Cleared
May 26, 2005
U-BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
50d
Cleared
May 20, 2005
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
79d
Cleared
Apr 06, 2005
TEGRESS IMPLANT NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
20d
Cleared
Apr 04, 2005
AIDA WITH DICOM AND HL7 INTERFACE
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
123d
Cleared
Mar 30, 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
13d
Cleared
Mar 18, 2005
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
FJL
Resectoscope
182d
Cleared
Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
PID
Esophageal Dilator Balloon With Or Without Electrode Sensors
38d
Cleared
Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
ODF
Mini Endoscope, Gastroenterology-urology
15d
Cleared
Feb 16, 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
FCG
Biopsy Needle
21d
Cleared
Dec 29, 2004
MODIFICATION TO: ZILVER 635 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
14d
Cleared
Dec 07, 2004
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
FAD
Stent, Ureteral
19d
Cleared
Nov 09, 2004
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
14d
Cleared
Nov 09, 2004
ENTERYX INJECTION CATHETER
FBK
Endoscopic Injection Needle, Gastroenterology-urology
21d
Cleared
Nov 08, 2004
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
11d
Cleared
Oct 25, 2004
SCB/VALLEYLAB FORCE FX INTERFACE UNIT
ODA
Endoscopic Central Control Unit
102d
Cleared
Oct 01, 2004
ZILVER 518 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
15d
Cleared
Oct 01, 2004
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
FGE
Stents, Drains And Dilators For The Biliary Ducts
72d
Cleared
Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
MQR
Stent, Colonic, Metallic, Expandable
59d
Cleared
Sep 29, 2004
BARDEX I.C. LATEX FOLEY CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
201d
Cleared
Aug 27, 2004
B. BRAUN BICARBONATE DIALYSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
67d
Cleared
Aug 27, 2004
ACCUSOL DIALYSIS SOLUTION
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
91d
Cleared
Aug 26, 2004
STORZ MODULITH, MODEL SLX-F2
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
184d
Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.
Search all Gastroenterology & Urology 510(k) devices