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

    QuikClot Control+

    K Number: K200167 · Decision Apr 23, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    5
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    QuikClot Control+
    K Number
    K200167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4454
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Z-Medica, LLC
    Date Received
    January 23, 2020
    Decision Date
    April 23, 2020
    Product Code
    POD
    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
    POD Temporary, Internal Use Hemostatic

    Similar 510(k) Clearances

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    QuikClot Control+ Hemostatic Dressing

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    Other Clearances by Z-Medica, LLC

    K Number Device Name
    K220971 QuikClot Control+ Hemostatic Dressing
    K181641 QuikClot Radial
    DEN160012 D2 Dressing
    K140757 D2 HEMOSTANTIC DRESSING
    K123387 QUIKCLOT HEMOSTATIC DRESSING