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

    THE NEEDLE CATCHER

    K Number: K051281 · Decision Sep 8, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    658
    Registration Numbers
    658
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    THE NEEDLE CATCHER
    K Number
    K051281
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.D.Medical , Ltd.
    Date Received
    May 17, 2005
    Decision Date
    September 8, 2005
    Product Code
    HTD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HTD Forceps

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