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510(k) Data Aggregation

    K Number
    K103412
    Device Name
    AXIOM FASCIAL CLOSURE SYSTEM
    Manufacturer
    AXIOM TECHNOLOGY PARTNERS, LLC
    Date Cleared
    2010-12-30

    (38 days)

    Product Code
    OCW, GCJ, HCF
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    AXIOM TECHNOLOGY PARTNERS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axiom Fascial Closure Device is used in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.
    Device Description
    A single-use medical device used to close laparoscopic trocar site defects. Closure of laparoscopic trocar site defects is used to reduce the risk of herniation which results in adverse effects to the patient and costly surgical revision by the healthcare provider. The Axiom Fascial Closure System provides mechanical assistance to assure reliable suture placement during fascial closure procedures.
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