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510(k) Data Aggregation

    K Number
    K240454
    Device Name
    RESPONDER® Polysaccharide Hemostat
    Manufacturer
    Starch Medical, Inc.
    Date Cleared
    2024-03-15

    (29 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Starch Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
    Device Description
    RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyroqenic and derived from plant starch. The device contains no human or animal components.
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    K Number
    K220525
    Device Name
    RESPONDER Polysaccharide Hemostat
    Manufacturer
    Starch Medical, Inc.
    Date Cleared
    2023-12-04

    (649 days)

    Product Code
    QSY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Starch Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RESPONDER® Polysaccharide Hemostat Rx is intended to be used to achieve hemostasis in emergency situations for the temporary control of severe topical bleeding. RESPONDER® Polysaccharide Hemostat OTC is indicated for the local management of bleeding such as lacerations, minor cuts and abrasions.
    Device Description
    RESPONDER® Polysaccharide Hemostat (RESPONDER®) is a medical device composed of absorbable modified polymer (AMP®) particles. AMP® particles are biocompatible, non-pyrogenic and derived from plant starch. The device contains no human or animal components.
    Ask a Question

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