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

    XSTAT

    K Number: DEN130016 · Decision Apr 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    7
    Review Days
    428

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    Basic Information

    Device Name
    XSTAT
    K Number
    DEN130016
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4452
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Revmedx, Inc.
    Date Received
    January 30, 2013
    Decision Date
    April 3, 2014
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (PGZ), ordered by most recent decision date.

    XSTAT P15

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    FDA Class 2 ·General, Plastic Surgery

    XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack

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    FDA Class 2 ·General, Plastic Surgery

    XSTAT-12, 3-Pack, XSTAT-12, 1-Pack

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    FDA Class 2 ·General, Plastic Surgery

    XSTAT 30, 3-PACK, XSTAT 30, 1-PACK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Revmedx, Inc.

    K Number Device Name
    K253290 XSTAT P15
    K210676 XSTAT 30 Pouch
    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