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

    Gem FlowCoupler System

    K Number: K191252 · Decision Jul 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    61

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    Basic Information

    Device Name
    Gem FlowCoupler System
    K Number
    K191252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Baxter/ Synovis Micro Companies Alliance, Inc.
    Date Received
    May 9, 2019
    Decision Date
    July 9, 2019
    Product Code
    MVR
    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
    MVR Device, Anastomotic, Microvascular

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    Other Clearances by Baxter/ Synovis Micro Companies Alliance, Inc.

    K Number Device Name
    K190499 Gem FlowCoupler System