FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
4345–4368 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 25, 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · FIP
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 192d
Cleared May 19, 2000
WALLSTENT BILIARY ENDOPROSTHESIS
K000308 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 108d
Cleared May 19, 2000
HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND...
K000723 · KOD
Rochester Medical Corp.
Gastroenterology & Urology · 74d
Cleared May 17, 2000
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18,...
K001222 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 17, 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13,...
K001224 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 12, 2000
WALLSTENT ENTERNAL PROSTHESIS
K000281 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 102d
Cleared May 12, 2000
URETHROTOME 8667.XXX AND 8670.XXX
K000905 · EZO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 52d
Cleared May 12, 2000
OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
K000948 · FEQ
Keymed (Medical & Industrial...
Gastroenterology & Urology · 50d
Cleared May 09, 2000
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
K000451 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared May 09, 2000
EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
K001241 · FDF
The Olympus Optical Co.
Gastroenterology & Urology · 21d
Cleared May 05, 2000
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111
K000386 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared May 03, 2000
H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K993520 · FIP
Serv-A-Pure Co.
Gastroenterology & Urology · 198d
Cleared May 01, 2000
BONE BIOPSY NEEDLE
K001132 · KNW
Promex, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 28, 2000
GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE
K001270 · FJL
Gyrus Medical , Ltd.
Gastroenterology & Urology · 8d
Cleared Apr 28, 2000
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149 · FJS
Medionics International, Inc.
Gastroenterology & Urology · 220d
Cleared Apr 24, 2000
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD,...
K000297 · FHN
Erchinger Medizintecnik
Gastroenterology & Urology · 84d
Cleared Apr 24, 2000
ACCUCORE SINGLE ACTION CORE BIOPSY DEVICE
K000612 · KNW
Inrad
Gastroenterology & Urology · 61d
Cleared Apr 18, 2000
THERMOFLEX SYSTEM
K000508 · KNS
Argomed, Inc.
Gastroenterology & Urology · 63d
Cleared Apr 17, 2000
WILSON-COOK COLONIC Z-STENT
K990034 · MQR
Med Institute, Inc.
Gastroenterology & Urology · 467d
Cleared Apr 17, 2000
IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
K991908 · FJI
Idemsa
Gastroenterology & Urology · 315d
Cleared Apr 14, 2000
INTRASTENT DOUBLESTRUT XS STENT
K000864 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 14, 2000
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991519 · FIP
Ameriwater
Gastroenterology & Urology · 350d
Cleared Apr 13, 2000
DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
K000646 · FBK
Enteric Medical Technologies
Gastroenterology & Urology · 48d
Cleared Apr 12, 2000
1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K000793 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d