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
2362 Gastroenterology & Urology devices
Cleared
Mar 23, 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Mar 20, 2000
BARD ENDOSCOPIC SUTURING SYSTEM
ODE
Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd)
90d
Cleared
Mar 16, 2000
MEMOTHERM COLORECTAL STENT
MQR
Stent, Colonic, Metallic, Expandable
393d
Cleared
Mar 07, 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
FHN
Ligator, Hemorrhoidal
29d
Cleared
Mar 03, 2000
KSEA SCB-RUI
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
71d
Cleared
Jan 31, 2000
BARD UROFORCE BALLOON DILATION CATHETER
EZN
Dilator, Catheter, Ureteral
80d
Cleared
Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
FFS
Image, Illumination, Fiberoptic, For Endoscope
48d
Cleared
Jan 20, 2000
HP M2376A DEVICE LINK SYSTEM
MQS
System, Hemodialysis, Access Recirculation Monitoring
90d
Cleared
Jan 18, 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
KNQ
Dilator, Esophageal
76d
Cleared
Jan 07, 2000
MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Jan 06, 2000
DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
FGE
Stents, Drains And Dilators For The Biliary Ducts
51d
Cleared
Jan 06, 2000
BARD MEMOTHERM FLEXX BILIARY STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
90d
Cleared
Dec 23, 1999
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
Cleared
Dec 10, 1999
BARDEX I.C. PEDIATRIC FOLEY CATHETER
MJC
Catheter, Urological (antimicrobial) And Accessories
58d
Cleared
Nov 28, 1999
S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Nov 24, 1999
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
89d
Cleared
Oct 29, 1999
PALMAZ XL TANSHEPATIC BILIARY STENTS
FGE
Stents, Drains And Dilators For The Biliary Ducts
43d
Cleared
Sep 10, 1999
BARD BALLOON INFLATION SYSTEM
KNT
Tubes, Gastrointestinal (and Accessories)
142d
Cleared
Aug 12, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
FGE
Stents, Drains And Dilators For The Biliary Ducts
87d
Cleared
Aug 04, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
FGE
Stents, Drains And Dilators For The Biliary Ducts
128d
Cleared
Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
MSD
Catheter, Hemodialysis, Implanted
375d
Cleared
Jul 06, 1999
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
FFS
Image, Illumination, Fiberoptic, For Endoscope
78d
Cleared
Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
MQR
Stent, Colonic, Metallic, Expandable
84d
Cleared
Jun 18, 1999
RENAL LINK
KPF
System, Dialysate Delivery, Semi-automatic, Peritoneal
88d
Cleared
Jun 11, 1999
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
MND
Ligator, Esophageal
87d
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