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510(k) Data Aggregation

    K Number
    K033762
    Device Name
    SERRALAPG
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2004-03-15

    (104 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERRALAPG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Serralapg™ Synthetic Surgical Absorbable Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in Ophthalmic, as a preliavascular and Neurological procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Serralapg™ Synthetic Surgical Absorbable Sutures). It does not contain any information about acceptance criteria or a study proving the device meets those criteria. My purpose is to extract information from the provided context, and in this case, the context does not contain the requested details.

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