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
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
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
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
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
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
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 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
Nov 26, 2003
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
MSD
Catheter, Hemodialysis, Implanted
43d
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