LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K981852
    Device Name
    SILIMED TISSUE EXPANDER
    Manufacturer
    SILIMED, LLC.
    Date Cleared
    1998-08-05

    (71 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 :

    SILIMED TISSUE EXPANDER

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

    Silimed 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

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, specifics of a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. This document is a 510(k) clearance letter from the FDA for a device called "Silimed Tissue Expander," outlining its regulatory status and intended use. It does not contain the detailed study information required to answer your request.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1