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
Apr 28, 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
47d
Cleared
Apr 27, 2004
RENACLEAN SH DIALYZER CLEANING SYSTEM
LIF
Dialyzer Reprocessing System
174d
Cleared
Apr 19, 2004
ANGIODYNAMICS, INC. MORE-FLOW HEMODIALYSIS CATHETER AND PROCEDURE KIT
MSD
Catheter, Hemodialysis, Implanted
62d
Cleared
Apr 15, 2004
VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM
FAJ
Cystoscope And Accessories, Flexible/rigid
76d
Cleared
Apr 14, 2004
MODIFICATION TO SURGICAL MESH POLYMERIC
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
16d
Cleared
Apr 08, 2004
ONEVIEW INTERFACE
FKP
System, Dialysate Delivery, Single Patient
85d
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
Apr 06, 2004
COOK URETERAL BALLOON DILATION CATHETER SET
EZN
Dilator, Catheter, Ureteral
76d
Cleared
Mar 30, 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
82d
Cleared
Mar 17, 2004
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
15d
Cleared
Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
MSD
Catheter, Hemodialysis, Implanted
19d
Cleared
Mar 16, 2004
ZILVER 635 BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
18d
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 27, 2004
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
GCA
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
37d
Cleared
Feb 20, 2004
MAMMOTOME EX HAND HELD SYSTEM
KNW
Instrument, Biopsy
87d
Cleared
Feb 20, 2004
WILSON-COOK USW CAP AND WIRE LOCK
OCY
Endoscopic Guidewire, Gastroenterology-urology
29d
Cleared
Feb 20, 2004
OASIS BILIARY STENT INTRODUCTION SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Feb 17, 2004
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
62d
Cleared
Feb 17, 2004
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
14d
Cleared
Feb 04, 2004
AMSURE RED RUBBER URETHRAL CATHETER
EYB
Catheter, Ureteral, Gastro-urology
372d
Cleared
Feb 04, 2004
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
91d
Cleared
Feb 04, 2004
BARD TIGERTAIL URETERAL CATHETER
KOD
Catheter, Urological
70d
Cleared
Jan 30, 2004
OLYMPUS VIDEO URETEROSCOPE, NTSC
FGB
Ureteroscope And Accessories, Flexible/rigid
71d
Cleared
Jan 30, 2004
FRESENIUS ULTRAFLO HPX HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
30d
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