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

    Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds

    K Number: K161358 · Decision Aug 3, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    23
    Review Days
    444

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds
    K Number
    K161358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings, Inc.
    Date Received
    May 16, 2016
    Decision Date
    August 3, 2017
    Product Code
    JCX
    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
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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