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

    Progenikine Concentrating System 25 mL System

    K Number: K191564 · Decision Nov 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    147

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    Basic Information

    Device Name
    Progenikine Concentrating System 25 mL System
    K Number
    K191564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Emcyte Corporation
    Date Received
    June 13, 2019
    Decision Date
    November 7, 2019
    Product Code
    MUU
    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
    MUU System, Suction, Lipoplasty

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    Other Clearances by Emcyte Corporation

    K Number Device Name
    K183205 PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System