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
2977–3000 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 24, 2008
SKATER BILIARY CATHETER
K073672 · FGE
Angiotech
Gastroenterology & Urology · 28d
Cleared Jan 22, 2008
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS...
K073093 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 82d
Cleared Jan 18, 2008
ENTERAL FEEDING SPIKE ADAPTER
K072652 · KNT
Cedic S.R.L.
Gastroenterology & Urology · 120d
Cleared Jan 14, 2008
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM,...
K071104 · FIP
Flier'S Quality Water Systems, Inc.
Gastroenterology & Urology · 270d
Cleared Jan 09, 2008
NEOMED Enteral FEEDING TUBE
K072881 · FPD
Neomed, Inc.
Gastroenterology & Urology · 92d
Cleared Jan 04, 2008
LITHOSKOP
K070665 · LNS
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 298d
Cleared Jan 04, 2008
MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM
K072684 · OCZ
Mondeal North America, Inc.
Gastroenterology & Urology · 105d
Cleared Dec 26, 2007
STORZ MODULITH LITHOTRIPTER SLX-F2-F180
K072788 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 86d
Cleared Dec 19, 2007
AMSURE BLADDER IRRIGATION SET
K070873 · LJH
Amsino Intl., Inc.
Gastroenterology & Urology · 265d
Cleared Dec 19, 2007
NON-IV ADAPTER FOR INFANT NG TUBE
K072756 · KNT
Promedic, Inc.
Gastroenterology & Urology · 83d
Cleared Dec 19, 2007
NEOMED URINARY CATHETER
K072997 · EZD
Neomed, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 18, 2007
VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM
K072180 · FAJ
Vision-Sciences, Inc.
Gastroenterology & Urology · 134d
Cleared Dec 14, 2007
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · KNT
Boston Scientific Corporation
Gastroenterology & Urology · 101d
Cleared Dec 13, 2007
GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
K072594 · FGA
Gyrus Acmi, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 07, 2007
BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY...
K070558 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 283d
Cleared Dec 07, 2007
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C....
K070582 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 281d
Cleared Dec 07, 2007
GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
K072354 · OCY
Accellent, Inc.
Gastroenterology & Urology · 107d
Cleared Dec 07, 2007
SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301
K072550 · KNT
Medevice, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 07, 2007
HEMAWAY SEAT
K072690 · LRL
Hemaway, LLC
Gastroenterology & Urology · 74d
Cleared Nov 30, 2007
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
K071202 · MSD
Dermaport, Inc.
Gastroenterology & Urology · 213d
Cleared Nov 30, 2007
BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
K072325 · MNW
Jawon Medical Co., Ltd.
Gastroenterology & Urology · 102d
Cleared Nov 29, 2007
HABIB ENDOBLATE
K072383 · KNS
Emcision , Ltd.
Gastroenterology & Urology · 97d
Cleared Nov 20, 2007
PEF TUBE
K071579 · KNT
N.M. Beale Co., Inc.
Gastroenterology & Urology · 165d
Cleared Nov 20, 2007
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521 · FFS
Cook Urological, Inc.
Gastroenterology & Urology · 74d