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510(k) Data Aggregation

    K Number
    K020265
    Device Name
    SERRALENE, MODEL CATALOG NO 1S
    Manufacturer
    SERRAL, S.A. DE C.V.
    Date Cleared
    2002-03-08

    (42 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SERRALENE, MODEL CATALOG NO 1S

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

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

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a medical device: Serralene™ Non-absorbable Surgical Sutures. This document does not contain the information requested about acceptance criteria and a study proving the device meets them.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on meeting specific, pre-defined acceptance criteria through a performance study. While the manufacturer would have performed tests to ensure the device's safety and effectiveness for substantial equivalence, the clearance letter itself doesn't typically detail those studies in the way you've outlined for AI/diagnostic devices.

    Therefore, I cannot extract the requested information from the provided text. The document is primarily an administrative letter granting clearance for marketing the device based on its substantial equivalence to an existing product.

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