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510(k) Data Aggregation

    K Number
    K982067
    Device Name
    MAGNETIC PORT SILICONE TISSUE EXPANDER
    Manufacturer
    SPECIALTY SURGICAL PRODUCTS, INC.
    Date Cleared
    1998-07-13

    (31 days)

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

    MAGNETIC PORT SILICONE TISSUE EXPANDER

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

    Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for a "Magnetic Port Silicone Tissue Expander." This document primarily deals with regulatory clearance based on substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

    Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study from the provided text. The document is about regulatory approval, not a performance study report.

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