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
2377–2400 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 18, 2012
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K111450 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 359d
Cleared May 18, 2012
CONCENTRIC BALLOON GOOGLE
K112698 · ODC
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 245d
Cleared May 18, 2012
SRS ENDOSCOPIC STAPLING SYSTEM
K120299 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 108d
Cleared May 17, 2012
EVOLUTION COLONIC STENT SYSTEM
K113510 · MQR
Cook Ireland, Ltd.
Gastroenterology & Urology · 171d
Cleared May 17, 2012
PRESTO BREAST BIOPSY DEVICE
K120440 · KNW
Sontina Medical, LLC
Gastroenterology & Urology · 94d
Cleared May 16, 2012
CLEARPATH LOWER GI
K113050 · FDF
Easyglide , Ltd.
Gastroenterology & Urology · 216d
Cleared May 16, 2012
CLEARPATH UPPER GI
K113166 · FDS
Easyglide , Ltd.
Gastroenterology & Urology · 202d
Cleared May 14, 2012
ROCAMED ROCAUS PLATINUM
K120160 · KNY
Promepla Sam
Gastroenterology & Urology · 116d
Cleared May 11, 2012
DOBBHOFF DUAL PORT FEEDING TUBE
K112511 · KNT
Covidien Lp, Formerly Registered AS...
Gastroenterology & Urology · 255d
Cleared May 11, 2012
LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM
K120821 · OCT
Misder, LLC
Gastroenterology & Urology · 53d
Cleared May 08, 2012
OPHIRA MINI SLING SYSTEM
K110420 · PAH
Promedon S.A
Gastroenterology & Urology · 449d
Cleared May 03, 2012
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL
K113660 · LKX
Cryotherapy Products, Inc.
Gastroenterology & Urology · 142d
Cleared May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Apr 27, 2012
NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER
K112314 · KDI
Nephros, Inc.
Gastroenterology & Urology · 260d
Cleared Apr 27, 2012
ENDOGATOR ADVANTAGE IRRIGATION PUMP
K113119 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 189d
Not Cleared Apr 27, 2012
PROSTATE MECHANICAL IMAGER
DEN100016 · OQT
Artann Laboratories, Inc.
Gastroenterology & Urology · 707d
Cleared Apr 26, 2012
FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
K112342 · KNT
Convatec, Inc.
Gastroenterology & Urology · 255d
Cleared Apr 24, 2012
APLAN A.V. FISTULA NEEDLE SET
K112734 · FIE
Aplan Well Enterprise Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Apr 24, 2012
FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
K120452 · FGE
Flexible Stenting Solutions, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 20, 2012
SAFETY SCREW CONNECTOR
K113719 · KNT
Abbott Laboratories
Gastroenterology & Urology · 123d
Cleared Apr 19, 2012
NEOMED GASTROINTESTINAL TUBE AND ACCESSORIES
K120182 · KNT
Neomed, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 17, 2012
LOFRIC SINGLE USE URINARY CATHETER
K113424 · EZD
Astra Tech AB
Gastroenterology & Urology · 148d
Cleared Apr 09, 2012
WEIGHT AND BODY FAT SCALE SHINE BS0105
K112149 · MNW
Shine Overseas Marketing Limited
Gastroenterology & Urology · 258d
Cleared Apr 06, 2012
IMAGE1 GI CCU MODEL 22203020-114
K111997 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 268d