BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit

    K Number: K254076 · Decision May 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    59
    Applicant Total
    645
    Review Days
    162

    Basic Information

    Device Name
    BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
    K Number
    K254076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    C.R. Bard, Inc.
    Date Received
    December 18, 2025
    Decision Date
    May 29, 2026
    Product Code
    FCM
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FCM), ordered by most recent decision date.

    Cure 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 (CS14C

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Self-Cath Closed System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMSELF CLOSED CATHETERIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AMSURE URETHRAL CATHETERIZATION TRAY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by C.R. Bard, Inc.

    K Number Device Name
    K252971 Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
    K251864 Rubber Utility Catheter
    K251186 Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
    K241334 Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,
    K230356 Aspirex™ Thrombectomy System
    K223177 Highlander™ 014 PTA Balloon Dilatation Catheter
    K222793 WavelinQ™ Generator
    K220270 Aspirex Thrombectomy System
    K213203 Provena(TM) Midline Catheter
    K212588 Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
    Search all 645 clearances from C.R. Bard, Inc. →