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
153d
Avg (2y)
1976
Since
2345 Gastroenterology & Urology devices
Cleared
Oct 20, 2006
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
KNW
Instrument, Biopsy
29d
Cleared
Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
KNQ
Dilator, Esophageal
87d
Cleared
Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
MQR
Stent, Colonic, Metallic, Expandable
74d
Cleared
Sep 11, 2006
RENALSOFT
KPF
System, Dialysate Delivery, Semi-automatic, Peritoneal
102d
Cleared
Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
122d
Cleared
May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
MQR
Stent, Colonic, Metallic, Expandable
92d
Cleared
Apr 27, 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
FKX
System, Peritoneal, Automatic Delivery
62d
Cleared
Feb 16, 2006
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
EZL
Catheter, Retention Type, Balloon
191d
Cleared
Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
76d
Cleared
Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
ODF
Mini Endoscope, Gastroenterology-urology
13d
Cleared
Aug 12, 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
MSD
Catheter, Hemodialysis, Implanted
44d
Cleared
Jul 18, 2005
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
LJE
Catheter, Nephrostomy
59d
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 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 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
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