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
2351 Gastroenterology & Urology devices
Cleared
Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
92d
Cleared
Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
208d
Cleared
Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
63d
Cleared
Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
FAD
Stent, Ureteral
20d
Cleared
Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Jan 05, 2001
BARD ENDOCINCH SUTURING SYSTEM # 000452
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
15d
Cleared
Jan 05, 2001
BARD LUMINEXX BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Jan 05, 2001
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
EZL
Catheter, Retention Type, Balloon
77d
Cleared
Dec 08, 2000
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
EZL
Catheter, Retention Type, Balloon
86d
Cleared
Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
FGE
Stents, Drains And Dilators For The Biliary Ducts
26d
Cleared
Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
MSE
Hemodialyzer, Re-use, Low Flux
167d
Cleared
Oct 12, 2000
NIR BILLIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Oct 06, 2000
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
ESW
Prosthesis, Esophageal
87d
Cleared
Oct 05, 2000
RAPID EXCHANGE TAPERTOME
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
27d
Cleared
Aug 30, 2000
MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
125d
Cleared
Jul 19, 2000
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
FFK
Lithotriptor, Electro-hydraulic
9d
Cleared
Jul 18, 2000
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jun 27, 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
70d
Cleared
Jun 02, 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
28d
Cleared
May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
FGE
Stents, Drains And Dilators For The Biliary Ducts
108d
Cleared
May 12, 2000
WALLSTENT ENTERNAL PROSTHESIS
MQR
Stent, Colonic, Metallic, Expandable
102d
Cleared
Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
OCW
Endoscopic Tissue Approximation Device
27d
Cleared
Mar 23, 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
171d
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