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510(k) Data Aggregation

    K Number
    K020597
    Device Name
    SERRALGUT
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-08-14

    (173 days)

    Product Code
    GAL
    Regulation Number
    878.4830
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERRALGUT

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

    SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a medical device (SERRALGut™ Suture). It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

    The letter is a regulatory document confirming that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It does not include the technical details of performance testing or clinical studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The requested information is not present in the document.

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