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
2623 Gastroenterology & Urology devices
Cleared
Aug 19, 2004
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207
FJL
Resectoscope
65d
Cleared
Jul 21, 2004
VIABIL BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
54d
Cleared
Jul 07, 2004
EXTRACTOR RX RETRIEVAL BALLOON
FGE
Stents, Drains And Dilators For The Biliary Ducts
22d
Cleared
May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
57d
Cleared
May 14, 2004
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
EZL
Catheter, Retention Type, Balloon
77d
Cleared
May 06, 2004
EASY CORE BIOPSY SYSTEM
FCG
Biopsy Needle
30d
Cleared
Apr 28, 2004
ENDOMAT LC PUMP, MODEL 20 3303 20
OCX
Endoscopic Irrigation/suction System
356d
Cleared
Apr 07, 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
FGE
Stents, Drains And Dilators For The Biliary Ducts
23d
Cleared
Mar 16, 2004
ZILVER 635 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
18d
Cleared
Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
MSD
Catheter, Hemodialysis, Implanted
19d
Cleared
Mar 12, 2004
TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
LQC
Lithotriptor, Biliary Mechanical
21d
Cleared
Mar 03, 2004
B.BRAUN PREMIXED DIALYSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
63d
Cleared
Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
62d
Cleared
Feb 04, 2004
BARD TIGERTAIL URETERAL CATHETER
KOD
Catheter, Urological
70d
Cleared
Feb 04, 2004
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
91d
Cleared
Jan 14, 2004
BARD ELIMINATOR PET BALLOON DILATORS
KNQ
Dilator, Esophageal
26d
Cleared
Dec 30, 2003
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
FED
Endoscopic Access Overtube, Gastroenterology-urology
26d
Cleared
Dec 22, 2003
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
60d
Cleared
Dec 15, 2003
ZILVER 518 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
56d
Cleared
Dec 12, 2003
FASTRAC GASTRIC ACCESS PORT KIT
KNT
Tubes, Gastrointestinal (and Accessories)
30d
Cleared
Dec 10, 2003
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Dec 08, 2003
GYNECARE TVT OBTURATOR SYSTEM
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
26d
Cleared
Nov 26, 2003
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
MSD
Catheter, Hemodialysis, Implanted
43d
Cleared
Nov 25, 2003
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
MMZ
Table, Cystometric, Electric
40d
Cleared
Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
174d
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