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

    CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)

    K Number: K192616 · Decision Oct 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    4
    Review Days
    28

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    Basic Information

    Device Name
    CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
    K Number
    K192616
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aziyo Biologics, Inc.
    Date Received
    September 23, 2019
    Decision Date
    October 21, 2019
    Product Code
    FTM
    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
    FTM Mesh, Surgical

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    Other Clearances by Aziyo Biologics, Inc.

    K Number Device Name
    K201313 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
    K182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
    K173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)