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
3001–3024 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 14, 2007
RESOLVE BILIARY DRAINAGE CATHETER
K063733 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 331d
Cleared Nov 09, 2007
SPEEDICATH COMPACT
K072808 · GBM
Coloplast Corp.
Gastroenterology & Urology · 39d
Cleared Nov 08, 2007
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
K062264 · FGE
Medtronic Vascular
Gastroenterology & Urology · 461d
Cleared Nov 02, 2007
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
K070643 · KDI
Gambro, Inc.
Gastroenterology & Urology · 239d
Cleared Nov 01, 2007
MODULARIS VARIOSTAR
K070799 · LNS
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 223d
Cleared Oct 31, 2007
GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
K072787 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 30, 2007
NOVOFLO CATHETER LT
K072499 · MSD
Novosci, Inc.
Gastroenterology & Urology · 55d
Cleared Oct 24, 2007
REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
K071764 · KNT
Obtech Medical Sarl
Gastroenterology & Urology · 117d
Cleared Oct 24, 2007
CYBERWAND STERILE PADS, MODEL: CW-RBPBX
K072422 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 57d
Cleared Oct 22, 2007
ONCONTROL BONE MARROW BIOPSY SYSTEM
K072045 · KNW
Vidacare Corporation
Gastroenterology & Urology · 89d
Cleared Oct 18, 2007
REDSENSE
K071013 · ODX
Redsense Medical AB
Gastroenterology & Urology · 191d
Cleared Oct 18, 2007
PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
K071909 · KOC
Barkey GmbH & Co. KG
Gastroenterology & Urology · 99d
Cleared Oct 18, 2007
ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT
K072125 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 16, 2007
DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR
K071049 · EZL
Tyco Healthcare
Gastroenterology & Urology · 186d
Cleared Oct 16, 2007
LIGHT SABRE SPINAL ACCESS DEVICE
K071814 · KNW
Minrad, Inc.
Gastroenterology & Urology · 106d
Cleared Oct 15, 2007
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K063788 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 298d
Cleared Oct 12, 2007
GAMBRO CARTRIDGE BLOOD SETS
K070414 · FJK
Gambro Renal Products
Gastroenterology & Urology · 242d
Cleared Oct 05, 2007
COLONIC & ENEMA NOZZLE
K071057 · KPL
Tiller Mind Body, Inc.
Gastroenterology & Urology · 172d
Cleared Oct 04, 2007
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL...
K072024 · FJK
Nipro Medical Corp.
Gastroenterology & Urology · 72d
Cleared Oct 02, 2007
REPROCESSED TROCARS
K070059 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 270d
Cleared Sep 28, 2007
MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
K061519 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 484d
Cleared Sep 26, 2007
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881 · FHN
Sapimed S.P.A.
Gastroenterology & Urology · 180d
Cleared Sep 18, 2007
ENDOSCOPIC PLICATION SYSTEM
K071553 · ODE
Ndo Surgical, Inc.
Gastroenterology & Urology · 104d
Cleared Sep 18, 2007
MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM
K071832 · LJH
Medical Scientific, Inc.
Gastroenterology & Urology · 77d