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510(k) Data Aggregation

    K Number
    K020146
    Device Name
    SERRALNYL
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-04-15

    (89 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERRALNYL

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

    SERRALNYL™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic and neurological procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for Serral S.A. de C.V.'s Serralny1™ Non-absorbable Surgical Sutures. It confirms that the device is substantially equivalent to legally marketed devices.

    However, this document does not contain any information regarding acceptance criteria, device performance, or any studies. The letter is a regulatory clearance and precedes the need for such data in a premarket notification, particularly for a Class II device like this, which is typically cleared based on substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information based on the provided text.

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