FDA.reportPublic FDA data

510(k) K254076

Device
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
Applicant
C.R. Bard, Inc.
510(k) number
K254076
Product code
FCM
Decision
Unknown (SESK)
Decision date
2026-05-29
Date received
2025-12-18
Regulation
876.5130
Classification name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
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
Marc Persad
Address
8195 Industrial Blvd. Covington GA US 30014 30014

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FCM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec Limited2025-06-06
K223821Self-Cath Closed SystemColoplast2023-08-02
K082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.2008-10-23
K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLC2007-06-01
K070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, Inc.2007-03-15
K030664AMSURE FOLEY INSERTION TRAYAmsino International, Inc.2003-05-23
K030712AMSURE URETHRAL CATHETERIZATION TRAYAmsino International, Inc.2003-05-23
K011055THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADSGo Medical Industries Pty. , Ltd.2001-06-06
K010420RUSCH MMG/O'NEIL CATHETERRusch, Inc.2001-05-09
K003873MENTOR SELF-CATH CLOSED SYSTEMMentor Corp.2001-03-29
K002803THE O'NEIL STERILE FIELD URINARY CATHETER KITGo Medical Industries Pty. , Ltd.2000-12-27
K983010SELF CATH SET/SAFETY CATHRusch Intl.1999-02-12
K963993RUSCH SIMPLASTIC FOLEY CATHETERIZATION SETRusch, Inc.1996-12-17
K962254NHMC URETHRAL CATHETERIZATION TRAYNational Healthcare Mfg. Corp.1996-07-29
K962073URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAYContinental Medical Laboratories, Inc.1996-06-21