BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    SAFESEAL REUSABLE URINAL SYSTEM

    K Number: K851682 · Decision Jun 24, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    21
    Applicant Total
    5
    Review Days
    62

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    Basic Information

    Device Name
    SAFESEAL REUSABLE URINAL SYSTEM
    K Number
    K851682
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dbt Medical , Ltd.
    Date Received
    April 23, 1985
    Decision Date
    June 24, 1985
    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

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    Other Clearances by Dbt Medical , Ltd.

    K Number Device Name
    K851681 SAFESTRETCH INCONTINENCE SYSTEM
    K851679 OSTOMY BAGS COLOSTOMY
    K851678 OSTOMY BAGS URETHEROSTOMY
    K851680 OSTOMY BAGS ILEOSTOMY