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
154d
Avg (2y)
1976
Since
2635 Gastroenterology & Urology devices
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 05, 2000
NEPHROSCOPE, 12 DEGREES
FGA
Kit, Nephroscope
173d
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
URETHROTOME 8667.XXX AND 8670.XXX
EZO
Urethrotome
52d
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
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
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