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 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
Cleared
Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
EYB
Catheter, Ureteral, Gastro-urology
91d
Cleared
Nov 06, 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
MND
Ligator, Esophageal
30d
Cleared
Oct 23, 2003
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ESW
Prosthesis, Esophageal
31d
Cleared
Oct 09, 2003
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
KLA
Monitor, Esophageal Motility, Anorectal Motility, And Tube
90d
Cleared
Oct 02, 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
30d
Cleared
Sep 29, 2003
KSEA MEDI PACK
GCT
Light Source, Endoscope, Xenon Arc
427d
Cleared
Sep 25, 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
87d
Cleared
Sep 23, 2003
KSEA OPSERVER LAP
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
96d
Cleared
Sep 17, 2003
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
68d
Cleared
Sep 04, 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
24d
Cleared
Aug 27, 2003
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Aug 06, 2003
SOFT-CELL DUAL LUMEN CATHETERS
MSD
Catheter, Hemodialysis, Implanted
191d
Cleared
Jul 30, 2003
NIAGARA TEMPORARY DUAL LUMEN CATHETERS
MPB
Catheter, Hemodialysis, Non-implanted
184d
Cleared
Jul 21, 2003
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
NFK
Kit, Repair, Catheter, Hemodialysis
160d
Cleared
Jul 14, 2003
ULTRAFLEX PRECISION COLONIC STENT
MQR
Stent, Colonic, Metallic, Expandable
125d
Cleared
Jul 07, 2003
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
27d
Cleared
Jun 27, 2003
ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT
KNT
Tubes, Gastrointestinal (and Accessories)
42d
Cleared
Jun 17, 2003
BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
158d
Cleared
Jun 16, 2003
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
61d
Cleared
Jun 16, 2003
HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
164d
Cleared
May 23, 2003
NAVIGATOR URETERAL ACCESS SHEATH SET
FED
Endoscopic Access Overtube, Gastroenterology-urology
57d
Cleared
May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
22d
Cleared
May 06, 2003
LUMINEXX ENDOSCOPIC BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
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