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
3649–3672 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 21, 2003
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES...
K030348 · FIP
Biolab Equipment Canada , Ltd.
Gastroenterology & Urology · 260d
Cleared Oct 16, 2003
STRYKER FLEXIBLE URETEROSCOPE
K031278 · FGB
Stryker Endoscopy
Gastroenterology & Urology · 177d
Cleared Oct 09, 2003
MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM
K030472 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 239d
Cleared Oct 09, 2003
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE...
K032138 · KLA
Medtronic Vascular
Gastroenterology & Urology · 90d
Cleared Oct 09, 2003
SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
K032506 · KNW
Sanarus Medical, Inc.
Gastroenterology & Urology · 56d
Cleared Oct 09, 2003
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
K032768 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 31d
Cleared Oct 03, 2003
VACURECT VACUUM CONSTRICTION DEVICE
K032776 · LKY
Vacurect Manufacturing (Pty) , Ltd.
Gastroenterology & Urology · 25d
Cleared Oct 02, 2003
AQUABOSS ECORO DIA 50
K032004 · FIP
Lauer Ltd., Hong Kong
Gastroenterology & Urology · 94d
Cleared Oct 02, 2003
GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE...
K032177 · FDS
Olympus Opto-Electronics Co., Ltd.
Gastroenterology & Urology · 78d
Cleared Oct 02, 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 30d
Cleared Sep 29, 2003
KSEA MEDI PACK
K022490 · GCT
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 427d
Cleared Sep 29, 2003
TORAYSULFONE DIALYZER, BS-L SERIES
K030050 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 266d
Cleared Sep 26, 2003
MAKY 21.1 DIALYZER REPROCESSING SYSTEM
K024076 · LIF
Hdc Maquinolas, LLC
Gastroenterology & Urology · 290d
Cleared Sep 26, 2003
EXCISOR BIOPTOME, MODEL 01-0004
K032847 · KNW
Acueity, Inc.
Gastroenterology & Urology · 14d
Cleared Sep 25, 2003
SENTINOL NITINOL BILLARY STENT SYSTEM
K032025 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 87d
Cleared Sep 24, 2003
GI SUPPLY BILIARY STENT
K031360 · FGE
Gi Supply
Gastroenterology & Urology · 147d
Cleared Sep 23, 2003
ROWENTA INC. BODYPARTNER VISION, MODEL BM 210 (2079565620)
K023429 · MNW
Rowenta, Inc.
Gastroenterology & Urology · 347d
Cleared Sep 23, 2003
KSEA OPSERVER LAP
K031895 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 96d
Cleared Sep 17, 2003
SORB+HISORB+CARTRIDGE
K031099 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 163d
Cleared Sep 17, 2003
FLEX-NECK PD CATHETER, INFANT
K031351 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 141d
Cleared Sep 17, 2003
CONDUCTIVITY STANDARD SOLUTION-METERCARE
K032075 · FKH
Ibp Instruments GmbH
Gastroenterology & Urology · 72d
Cleared Sep 17, 2003
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032137 · FGE
Cordis Corp.
Gastroenterology & Urology · 68d
Cleared Sep 15, 2003
PRISMA M60/M100 SETS
K032431 · KDI
Gambro, Inc.
Gastroenterology & Urology · 40d
Cleared Sep 05, 2003
ACUEITY MEDICAL LIGHT SOURCE
K032430 · FCW
Acueity, Inc.
Gastroenterology & Urology · 30d