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
4129–4152 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 02, 2001
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
K011368 · KPO
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Aug 01, 2001
SPARC SLING SYSTEM
K011251 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 99d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K012056 · FGE
Cordis Europa, N.V.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012066 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012090 · FGE
Cordis, A Johnson & Johnson Co.
Gastroenterology & Urology · 27d
Not Cleared Aug 01, 2001
GIVEN DIAGNOSTIC IMAGING SYSTEM
DEN010002 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 51d
Cleared Jul 31, 2001
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
K003580 · FFX
Unisensor AG
Gastroenterology & Urology · 253d
Cleared Jul 31, 2001
R STENT BILIARY ENDOPROSTHESIS
K010107 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 200d
Cleared Jul 25, 2001
TACKER, MODEL R65-933
K003949 · OCW
A & A Medical, Inc.
Gastroenterology & Urology · 216d
Cleared Jul 25, 2001
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · EZL
Applied Medical Resources Corp.
Gastroenterology & Urology · 204d
Cleared Jul 25, 2001
MEDIFIX URETEROSCOPE
K011325 · FGB
Medifix, Inc.
Gastroenterology & Urology · 85d
Cleared Jul 24, 2001
VACUUM ASSISTED CORE BIOPSY DEVICE
K010400 · KNW
Promex, Inc.
Gastroenterology & Urology · 162d
Cleared Jul 18, 2001
PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
K011206 · KNW
Parallax Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 18, 2001
UROLOGICAL CATHETER
K011552 · GBM
Apogee Medical, Inc.
Gastroenterology & Urology · 61d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared Jul 17, 2001
MESH URETERAL STENT
K011264 · FAD
Applied Medical Resources Corp.
Gastroenterology & Urology · 83d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 18d
Cleared Jul 12, 2001
DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT
K011862 · KPM
Denver Biomedical, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 11, 2001
RECTOSIGHT RS300-04
K011825 · FER
Sightline Technologies , Ltd.
Gastroenterology & Urology · 30d
Cleared Jul 09, 2001
GASTRIC SUCTION AND DRAINAGE CATHETER
K002838 · KNT
Bioenterics Corp.
Gastroenterology & Urology · 300d
Cleared Jul 06, 2001
PRECISION TUNA OFFICE SYSTEM WITH NO RECTAL TEMPERATURE MONITORING TAPE
K011787 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 03, 2001
BODYSTAT
K002835 · MNW
Bodystat , Ltd.
Gastroenterology & Urology · 294d
Cleared Jun 27, 2001
EASYBELL
K011075 · FCG
Biopsybell S.A.S.
Gastroenterology & Urology · 79d