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
3433–3456 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 02, 2004
MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
K043027 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 24, 2004
15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER
K040328 · MSD
Medcomp
Gastroenterology & Urology · 288d
Cleared Nov 24, 2004
FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
K042043 · FDS
Fujinon, Inc.
Gastroenterology & Urology · 118d
Cleared Nov 24, 2004
NX STAGE WATER PURIFICATION SYSTEM
K042089 · FIP
Nxstage Medical, Inc.
Gastroenterology & Urology · 113d
Cleared Nov 24, 2004
GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
K042960 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 28d
Cleared Nov 18, 2004
FUJINON G5 DUODENSCOPES
K042076 · FDT
Fujinon, Inc.
Gastroenterology & Urology · 108d
Cleared Nov 17, 2004
OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016
K041983 · EZL
Opticon Medical
Gastroenterology & Urology · 117d
Cleared Nov 16, 2004
MICROVERTER URETERAL ACCESS SHEATH
K042877 · KNY
Percutaneous Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 15, 2004
STERICHEK GLUTARALDEHYDE REAGENT STRIPS
K040660 · LIF
Hach Company
Gastroenterology & Urology · 248d
Cleared Nov 10, 2004
FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5
K041903 · FDF
Fujinon, Inc.
Gastroenterology & Urology · 119d
Cleared Nov 09, 2004
MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
K042851 · OTN
Mentor Corp.
Gastroenterology & Urology · 25d
Cleared Nov 09, 2004
ENTERYX INJECTION CATHETER
K042882 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Nov 09, 2004
PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)
K042949 · PAG
C.R. Bard, Inc.
Gastroenterology & Urology · 14d
Cleared Nov 08, 2004
VASC-ALERT
K042566 · MQS
Vasc-Alert, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 08, 2004
MAMMOTOME MR BIOPSY SYSTEM
K042753 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 35d
Cleared Nov 08, 2004
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K042969 · FGE
Cordis Corp.
Gastroenterology & Urology · 11d
Cleared Nov 05, 2004
BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER
K041464 · EZD
Busse Hospital Disposables
Gastroenterology & Urology · 156d
Cleared Nov 05, 2004
KENDALL CO2NFIRM NOW CO2 DETECTOR
K042572 · KNT
Kendall
Gastroenterology & Urology · 45d
Cleared Nov 05, 2004
CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE
K042615 · FBK
Carbon Medical Technologies, Inc.
Gastroenterology & Urology · 42d
Cleared Nov 05, 2004
K.E.P. CONNECTOR AND CLIP
K042900 · KDJ
K.E.P., LLC
Gastroenterology & Urology · 17d
Cleared Nov 01, 2004
GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
K040301 · MPB
Gambro Renal Products
Gastroenterology & Urology · 266d
Cleared Oct 29, 2004
MENTOR GENESIS PENILE PROSTHESIS
K040959 · FAE
Mentor Corp.
Gastroenterology & Urology · 199d
Cleared Oct 25, 2004
GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
K041149 · NSI
Given Imaging , Ltd.
Gastroenterology & Urology · 175d
Cleared Oct 25, 2004
SCB/VALLEYLAB FORCE FX INTERFACE UNIT
K041912 · ODA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 102d