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
2041–2064 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 15, 2014
ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM
K140753 · OCX
Medivators
Gastroenterology & Urology · 111d
Cleared Jul 09, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K134005 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 194d
Cleared Jul 07, 2014
ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLY
K133299 · KDI
Fresenius Medical Care, North America...
Gastroenterology & Urology · 255d
Cleared Jul 07, 2014
VECTORFLOW
K141051 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 74d
Cleared Jul 02, 2014
EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
K133110 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 275d
Cleared Jul 01, 2014
DESARA BLUE OV, DESARA BLUE SS
K140843 · OTN
Caldera Medical
Gastroenterology & Urology · 90d
Cleared Jun 30, 2014
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K140751 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 97d
Cleared Jun 26, 2014
CONSURE STOOL MANAGEMENT SYSTEM
K133465 · KNT
Consure Medical Pvt , Ltd.
Gastroenterology & Urology · 226d
Cleared Jun 19, 2014
ABBVIE PEG
K133087 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 262d
Cleared Jun 19, 2014
ABBVIE NJ
K133129 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 262d
Cleared Jun 18, 2014
ABB VIE J
K133096 · KNT
AbbVie, Inc.
Gastroenterology & Urology · 261d
Cleared Jun 18, 2014
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS...
K141363 · MSD
Merit Medical Systems, Inc.
Gastroenterology & Urology · 26d
Cleared Jun 17, 2014
BI-FLEX URETERAL ACCESS SHEATH
K140441 · KNY
Promepla Sam
Gastroenterology & Urology · 116d
Cleared Jun 16, 2014
PILLING ESOPHAGEAL BOUGIES
K133439 · FAT
Teleflexmedical, Inc.
Gastroenterology & Urology · 216d
Cleared Jun 16, 2014
WIJAY EZ-VOID EXTERNAL CATHETER VALVE
K140562 · KNY
Leomed, LLC
Gastroenterology & Urology · 103d
Cleared Jun 16, 2014
NXSTAGE EXPRESS FLUID WARMER
K140623 · FLA
Nxstage Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Jun 16, 2014
BONASTENT BILIARY
K140760 · FGE
Endochoice, Inc.
Gastroenterology & Urology · 82d
Cleared Jun 11, 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K141250 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 10, 2014
AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM
K141019 · LKN
Fenwal, Inc.
Gastroenterology & Urology · 50d
Cleared Jun 09, 2014
GUARDIAN URETHRAL SHEATH
K141252 · KNY
Solace Therapeutics
Gastroenterology & Urology · 26d
Cleared Jun 03, 2014
MED-RX ORAL/ENTERAL SYRINGE
K131183 · KNT
Benlan, Inc.
Gastroenterology & Urology · 403d
Cleared Jun 02, 2014
ARIA WIFI SMART SCALE
K133872 · MNW
Fitbit, Inc.
Gastroenterology & Urology · 164d
Cleared May 30, 2014
BODY FAT ANALYZER AND SCALE
K140594 · MNW
Conmo Electronic Company Limited
Gastroenterology & Urology · 84d
Cleared May 23, 2014
SHERPA PAK TRANSPORTER
K133694 · KDN
Paragonix Technologies, Inc.
Gastroenterology & Urology · 171d