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
May 09, 2000
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
FDF
Colonoscope And Accessories, Flexible/rigid
21d
Cleared
May 05, 2000
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
FFX
System, Gastrointestinal Motility (electrical)
88d
Cleared
May 03, 2000
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
198d
Cleared
May 01, 2000
BONE BIOPSY NEEDLE
KNW
Instrument, Biopsy
21d
Cleared
Apr 28, 2000
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
FJL
Resectoscope
8d
Cleared
Apr 28, 2000
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
FJS
Catheter, Peritoneal, Long-term Indwelling
220d
Cleared
Apr 24, 2000
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER
FHN
Ligator, Hemorrhoidal
84d
Cleared
Apr 24, 2000
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
KNW
Instrument, Biopsy
61d
Cleared
Apr 18, 2000
THERMOFLEX SYSTEM
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
63d
Cleared
Apr 17, 2000
WILSON-COOK COLONIC Z-STENT
MQR
Stent, Colonic, Metallic, Expandable
467d
Cleared
Apr 17, 2000
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
FJI
Dialyzer, Capillary, Hollow Fiber
315d
Cleared
Apr 14, 2000
INTRASTENT DOUBLESTRUT XS STENT
FGE
Stents, Drains And Dilators For The Biliary Ducts
28d
Cleared
Apr 14, 2000
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
350d
Cleared
Apr 13, 2000
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
FBK
Endoscopic Injection Needle, Gastroenterology-urology
48d
Cleared
Apr 12, 2000
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
Cleared
Apr 10, 2000
PRO.DUCT CATHETER, MODEL CTH03
KNW
Instrument, Biopsy
83d
Cleared
Apr 10, 2000
DIGITAL INFLECTION RIGIDOMETER (DIR)
LIL
Monitor, Penile Tumescence
80d
Cleared
Apr 10, 2000
MODIFICATION TO JMS APHERESIS NEEDLE
FIE
Needle, Fistula
26d
Cleared
Apr 10, 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
FIE
Needle, Fistula
26d
Cleared
Apr 10, 2000
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
FIN
Tank, Holding, Dialysis
193d
Cleared
Apr 04, 2000
RENAFLO II HF 2000 HEMOFILTER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
90d
Cleared
Mar 30, 2000
SMITH & NEPHEW SUTURELOK, MODEL 7207321
OCW
Endoscopic Tissue Approximation Device
27d
Cleared
Mar 30, 2000
OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENT
FAJ
Cystoscope And Accessories, Flexible/rigid
202d
Cleared
Mar 23, 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
FGE
Stents, Drains And Dilators For The Biliary Ducts
30d
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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