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

    RESPONDER® Polysaccharide Hemostat

    K Number: K240454 · Decision Mar 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    115
    Applicant Total
    2
    Review Days
    29

    Basic Information

    Device Name
    RESPONDER® Polysaccharide Hemostat
    K Number
    K240454
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Starch Medical, Inc.
    Date Received
    February 15, 2024
    Decision Date
    March 15, 2024
    Product Code
    QSY
    Advisory Committee
    Unknown
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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    Other Clearances by Starch Medical, Inc.

    K Number Device Name
    K220525 RESPONDER Polysaccharide Hemostat