BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SILICONE MALE EXTERNAL CATHETER

    K Number: K913524 · Decision Oct 4, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    61
    Review Days
    57

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SILICONE MALE EXTERNAL CATHETER
    K Number
    K913524
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mentor Corp.
    Date Received
    August 8, 1991
    Decision Date
    October 4, 1991
    Product Code
    EXJ
    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
    EXJ Device, Incontinence, Urosheath Type, Sterile

    Similar 510(k) Clearances

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

    BOUSER'S URINAL

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    COMFORT CATH CHOICE MALE EXTERNAL CATHETER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    PROSYS SAMEC LA

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    SELF RETAINING MALE EXTERNAL URINARY CATHETER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology
    View all

    Other Clearances by Mentor Corp.

    K Number Device Name
    K130813 MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
    K053414 MENTOR NOVASILK MESH
    K050008 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
    K042851 MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT
    K040959 MENTOR GENESIS PENILE PROSTHESIS
    K031767 MENTOR OBTAPE TRANS-OBTURATOR TAPE
    K011493 MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
    K011500 MENTOR CONTOUR PROFILE TISSUE EXPANDER
    K004005 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
    K010709 MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
    Search all 61 clearances from Mentor Corp. →