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
2425–2448 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 16, 2012
EVIS EXERA III VIDEO SYSTEM
K112680 · FDF
Olympus Medical Systems Corporation
Gastroenterology & Urology · 155d
Cleared Feb 14, 2012
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT
K113496 · OTM
Coloplast A/S
Gastroenterology & Urology · 81d
Cleared Feb 14, 2012
ESOPHAGEAL TTS STENT
K113551 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 75d
Cleared Feb 14, 2012
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE
K113634 · FBK
Cook Ireland, Ltd.
Gastroenterology & Urology · 67d
Cleared Feb 13, 2012
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP...
K111405 · GBM
Hangzhou Bever Medical Devices Co., Ltd.
Gastroenterology & Urology · 270d
Cleared Feb 10, 2012
CRE DITATATION BALLON
K112994 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 126d
Cleared Feb 06, 2012
NAVIAID ICVI-F,S,B,R DEVICE
K112106 · ODC
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 199d
Cleared Feb 02, 2012
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM
K120017 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Jan 26, 2012
BICARB MIXING AND DISTRIBUTION SYSTEM
K112427 · FIN
Isopure, Corp.
Gastroenterology & Urology · 156d
Cleared Jan 25, 2012
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K112576 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 141d
Cleared Jan 20, 2012
SPECTRA OPTIA APHERESIS SYSTEM
K113480 · LKN
Caridianbct, Inc..
Gastroenterology & Urology · 58d
Cleared Jan 12, 2012
LUCEA LED SURGICAL LIGHT SYSTEM
K113679 · NTN
Maquet S.A.S.
Gastroenterology & Urology · 29d
Cleared Jan 10, 2012
CORTRAK ENTERAL ACCESS DEVICE
K113351 · KNT
Corpak Medsystems
Gastroenterology & Urology · 57d
Cleared Jan 06, 2012
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
K111165 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 255d
Cleared Dec 30, 2011
HANAROSTENT BILIARY (NNN)
K111149 · FGE
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 249d
Cleared Dec 30, 2011
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K112522 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 121d
Cleared Dec 29, 2011
WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY...
K112543 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 119d
Cleared Dec 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
K113427 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Dec 20, 2011
KIM
K103022 · OTN
Neomedic International S.L.
Gastroenterology & Urology · 434d
Cleared Dec 19, 2011
ACEM
K111013 · FFZ
Sandhill Scientific, Inc.
Gastroenterology & Urology · 252d
Cleared Dec 16, 2011
MED GRAVITY SET, IMED PUMP SET
K102712 · KNT
Imed Technology, Inc.
Gastroenterology & Urology · 452d
Cleared Dec 16, 2011
AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION...
K110793 · MPB
Ameco Medical Industries
Gastroenterology & Urology · 269d
Cleared Dec 08, 2011
SPLIT CATH III
K111651 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 178d
Cleared Nov 30, 2011
DESARA MINI
K103418 · PAH
Caldera Medical, Inc.
Gastroenterology & Urology · 373d