FDA.reportPublic FDA data

510(k) K260919

Device
Transurethral Catheter Safety Valve (TUCSV) (80050)
Applicant
Class Medical , Ltd.
510(k) number
K260919
Product code
KNY
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-05
Date received
2026-03-19
Regulation
876.5130
Classification name
Accessories, Catheter, G-U
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Danny Forde
Address
Unit 1d Annacotty Business Park Annacotty Co Limerick IE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KNY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182144Bi-Flex EvoPromepla Sam2018-09-07
K162356Vesair Cystoscopic SheathSolace Therapeutics2017-03-02
K140441BI-FLEX URETERAL ACCESS SHEATHPromepla Sam2014-06-17
K140562WIJAY EZ-VOID EXTERNAL CATHETER VALVELeomed, LLC2014-06-16
K141252GUARDIAN URETHRAL SHEATHSolace Therapeutics2014-06-09
K131803GUARDIAN URETHRAL SHEATHSolace Therapeutics2013-08-20
K123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies America2013-02-04
K120160ROCAMED ROCAUS PLATINUMPromepla Sam2012-05-14
K112209PREFILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2011-09-08
K090121PRE-FILLED CATHETER INFLATION SYRINGEAvail Medical Products, Inc.2009-04-15
K052298CYSTOGLIDE INTRODUCER SHEATHPercutaneous Systems, Incorporated2006-12-12
K062240CAREVENTChief Medical, LLC2006-10-16
K052952CATHASSISTPhysician Technologies, Inc.2006-05-14
K052134CYSTOGLIDE DILATING INTRODUCER SHEATHPercutaneous Systems, Inc.2005-09-22
K051593UROPASS URETERAL ACCESS SHEATH, MODEL 61224Acmi Corporation2005-09-02