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
2761–2784 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 12, 2009
OMNISURE URETHRAL SLING, MODEL OTK52
K092203 · OTN
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 21d
Cleared Aug 10, 2009
AMSURE HYDROPHILIC LATEX FOLEY CATHETER
K091699 · EZL
Amsino International, Inc.
Gastroenterology & Urology · 61d
Cleared Aug 07, 2009
ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X...
K090002 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 217d
Cleared Aug 07, 2009
FUJINON STERILE OVERTUBES
K091773 · FED
Fujinon, Inc.
Gastroenterology & Urology · 52d
Cleared Jul 29, 2009
BULLSEYE BILIARY STENT SYSTEM
K082093 · FGE
Squareone
Gastroenterology & Urology · 370d
Cleared Jul 29, 2009
MODIFICATION TO OLYMPUS CAPSULE ENDOSCOPE SYSTEM
K090210 · NEZ
Olympus Medical Systems Corporation
Gastroenterology & Urology · 182d
Cleared Jul 29, 2009
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT
K091405 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 78d
Cleared Jul 28, 2009
HAEMOBAND MULTI-LIGATOR
K091519 · FHN
Haemoband Surgical, Ltd.
Gastroenterology & Urology · 67d
Cleared Jul 28, 2009
PLS PORTABLE LIGHT SOURCE
K091829 · NTN
Optim, Inc.
Gastroenterology & Urology · 39d
Cleared Jul 27, 2009
SONOLITH I-SYS LITHOTRIPER
K083614 · LNS
Technomed Medical Systems, SA
Gastroenterology & Urology · 231d
Cleared Jul 23, 2009
INSUFLOW CO2IONSHIELD
K090879 · FCX
Lexion Medical, LLC
Gastroenterology & Urology · 114d
Cleared Jul 22, 2009
COAXIAL ACCORDION ERCP DEVICE, MODELS C0AC19001, COAC20005, COAC22003
K090485 · LQR
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 147d
Cleared Jul 22, 2009
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
K091355 · FDI
Conmed Endoscopic Technologies, Inc.
Gastroenterology & Urology · 75d
Cleared Jul 22, 2009
ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER
K091832 · OCW
Endogastric Solutions, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 21, 2009
LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP
K090830 · FBK
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 117d
Cleared Jul 20, 2009
DERMAPORT PORTED VASCULAR ACCESS SYSTEM (PVAS)
K091760 · MSD
Dermaport, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 14, 2009
NUTRAC PELVATOR, MODEL PEL 200
K083704 · KPI
Verity Scientific , Ltd.
Gastroenterology & Urology · 211d
Cleared Jul 14, 2009
MINITAPE URETHRAL SLING
K091180 · PAH
Mpathy Medical Devices, Ltd.
Gastroenterology & Urology · 82d
Cleared Jul 10, 2009
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
K083712 · FIP
Dipure, LLC
Gastroenterology & Urology · 207d
Cleared Jul 10, 2009
COOK UROLOGICAL GRAFT
K090688 · PAG
Cook Biotech, Inc.
Gastroenterology & Urology · 116d
Cleared Jul 07, 2009
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
K090479 · MNW
Tanita Corporation of America
Gastroenterology & Urology · 133d
Cleared Jul 07, 2009
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
K091783 · FDF
Avantis Medical Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Jul 02, 2009
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL...
K090851 · ODC
Byrne Medical, Inc.
Gastroenterology & Urology · 94d
Cleared Jul 01, 2009
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 13d