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
9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8435 Gastroenterology & Urology devices
Cleared
Aug 05, 1999
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
MSB
System And Accessories, Isolated Heart, Transport And Preservation
90d
Cleared
Aug 05, 1999
FLEXISCOPE IQ 101
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
21d
Cleared
Aug 04, 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
FGE
Stents, Drains And Dilators For The Biliary Ducts
128d
Cleared
Aug 04, 1999
INTRASTENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
57d
Cleared
Aug 04, 1999
FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
28d
Cleared
Aug 02, 1999
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
FGE
Stents, Drains And Dilators For The Biliary Ducts
140d
Cleared
Aug 02, 1999
MEDTRONIC AVE BRIDGE STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
21d
Cleared
Jul 30, 1999
FRESENIUS ON LINE CLEARANCE MONITOR WITH THE ADDITION OF ACCESS FLOW DETERMINATION
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
88d
Cleared
Jul 30, 1999
CRIT-LINE MONITOR III (CLM III)
MQS
System, Hemodialysis, Access Recirculation Monitoring
28d
Cleared
Jul 29, 1999
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
FJI
Dialyzer, Capillary, Hollow Fiber
90d
Cleared
Jul 29, 1999
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
FGE
Stents, Drains And Dilators For The Biliary Ducts
87d
Cleared
Jul 27, 1999
SWISS LITHOCLAST MULTIPURPOSE PROBE
FFK
Lithotriptor, Electro-hydraulic
21d
Cleared
Jul 26, 1999
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
KNT
Tubes, Gastrointestinal (and Accessories)
73d
Cleared
Jul 15, 1999
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
FFX
System, Gastrointestinal Motility (electrical)
85d
Cleared
Jul 14, 1999
ELECTRO MECHANICAL LITHOTRIPTOR
FFK
Lithotriptor, Electro-hydraulic
161d
Cleared
Jul 14, 1999
SMITH & NEPHEW SUTURE LOK
OCW
Endoscopic Tissue Approximation Device
76d
Cleared
Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
MSD
Catheter, Hemodialysis, Implanted
375d
Cleared
Jul 07, 1999
VISER PENILE TUMESCENCE MONITOR
LIL
Monitor, Penile Tumescence
70d
Cleared
Jul 06, 1999
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
FFS
Image, Illumination, Fiberoptic, For Endoscope
78d
Cleared
Jul 02, 1999
DD URETERAL STENT, INTEGRAL STENT
FAD
Stent, Ureteral
311d
Cleared
Jun 29, 1999
GYRUS ENDOUROLOGY SYSTEM
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
124d
Cleared
Jun 29, 1999
COAGULOOP
FAS
Electrode, Electrosurgical, Active, Urological
74d
Cleared
Jun 25, 1999
ASH ADVANTAGE PERITONEAL CATHETER
FJS
Catheter, Peritoneal, Long-term Indwelling
88d
Cleared
Jun 25, 1999
DAUM MRI/CONVENTIONAL BIOPSY KIT
KNW
Instrument, Biopsy
66d
Cleared
Jun 25, 1999
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
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