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

    XSTAT 30 Pouch

    K Number: K210676 · Decision Aug 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    175

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    Basic Information

    Device Name
    XSTAT 30 Pouch
    K Number
    K210676
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4452
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Revmedx, Inc.
    Date Received
    March 5, 2021
    Decision Date
    August 27, 2021
    Product Code
    PGZ
    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
    PGZ Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

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    Other Clearances by Revmedx, Inc.

    K Number Device Name
    K253290 XSTAT P15
    K180051 XSTAT 30, 1-Pack
    K170334 XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
    K161020 XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
    K152624 XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
    DEN130016 XSTAT