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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8421 Gastroenterology & Urology devices
Cleared
Oct 29, 2004
MENTOR GENESIS PENILE PROSTHESIS
FAE
Prosthesis, Penile
199d
Cleared
Oct 25, 2004
GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
NSI
System, Imaging, Esophageal, Wireless, Capsule
175d
Cleared
Oct 25, 2004
SCB/VALLEYLAB FORCE FX INTERFACE UNIT
ODA
Endoscopic Central Control Unit
102d
Cleared
Oct 25, 2004
AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
62d
Cleared
Oct 25, 2004
URO PRO
LJH
System, Irrigation, Urological
45d
Cleared
Oct 22, 2004
RM3 RENAL PRESERVATION SYSTEM
KDN
System, Perfusion, Kidney
66d
Cleared
Oct 20, 2004
MEGA PURE CART
FIP
Subsystem, Water Purification
495d
Cleared
Oct 15, 2004
MODIFICATION TO URETERAL STENT
FAD
Stent, Ureteral
204d
Cleared
Oct 12, 2004
TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
21d
Cleared
Oct 07, 2004
GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
171d
Cleared
Oct 07, 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
FIP
Subsystem, Water Purification
157d
Cleared
Oct 06, 2004
VACUUM ASSISTED CORE BIOPSY DEVICE
KNW
Instrument, Biopsy
43d
Cleared
Oct 04, 2004
VARICES NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
535d
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
Oct 01, 2004
ZILVER 518 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
15d
Cleared
Sep 30, 2004
WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
MQR
Stent, Colonic, Metallic, Expandable
59d
Cleared
Sep 30, 2004
V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
KNW
Instrument, Biopsy
17d
Cleared
Sep 29, 2004
BARDEX I.C. LATEX FOLEY CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
201d
Cleared
Sep 27, 2004
PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
73d
Cleared
Sep 24, 2004
FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
KDJ
Set, Administration, For Peritoneal Dialysis, Disposable
84d
Cleared
Sep 23, 2004
DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
58d
Cleared
Sep 21, 2004
CAVERMAP SURGICAL AID
FGM
Probe And Director, Gastro-urology
88d
Cleared
Sep 16, 2004
MEDCOMP T-3
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
309d
Cleared
Sep 10, 2004
5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
NQJ
Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use
70d
Cleared
Sep 10, 2004
ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
FAJ
Cystoscope And Accessories, Flexible/rigid
24d
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