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510(k) Data Aggregation

    K Number
    K964547
    Device Name
    DEGANIA SILICONE INDENTI LOOPS
    Manufacturer
    DEGANIA SILICONE, LTD.
    Date Cleared
    1997-01-08

    (56 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation.

    Device Description

    The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loop is not designed nor indicated for Implantation. Previously 2 sizes Mini and Maxi were available, we have now added Super Maxi (Extra Maxi).

    AI/ML Overview

    This document is a 510(k) summary for the Degania Silicone Identi Loops, specifically addressing the addition of a "Super Maxi" size. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory submission for a new size of an existing device, emphasizing its substantial equivalence to previous versions, rather than new performance testing.

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