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
9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5369 Gastroenterology & Urology devices
Cleared
Nov 24, 2004
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
MSD
Catheter, Hemodialysis, Implanted
288d
Cleared
Nov 24, 2004
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
FDS
Gastroscope And Accessories, Flexible/rigid
118d
Cleared
Nov 24, 2004
NX STAGE WATER PURIFICATION SYSTEM
FIP
Subsystem, Water Purification
113d
Cleared
Nov 24, 2004
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
NSI
System, Imaging, Esophageal, Wireless, Capsule
28d
Cleared
Nov 18, 2004
FUJINON G5 DUODENSCOPES
FDT
Duodenoscope And Accessories, Flexible/rigid
108d
Cleared
Nov 10, 2004
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
FDF
Colonoscope And Accessories, Flexible/rigid
119d
Cleared
Nov 09, 2004
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
25d
Cleared
Nov 09, 2004
ENTERYX INJECTION CATHETER
FBK
Endoscopic Injection Needle, Gastroenterology-urology
21d
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 08, 2004
MAMMOTOME MR BIOPSY SYSTEM
KNW
Instrument, Biopsy
35d
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 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 15, 2004
MODIFICATION TO URETERAL STENT
FAD
Stent, Ureteral
204d
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 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 16, 2004
MEDCOMP T-3
NIE
Catheter, Hemodialysis, Triple Lumen, Non-implanted
309d
Cleared
Aug 27, 2004
ACCUSOL DIALYSIS SOLUTION
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
91d
Cleared
Aug 27, 2004
B. BRAUN BICARBONATE DIALYSATE
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
67d
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