BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    SEARE BIOMEDICAL SILICONE TISSUE EXPANDER

    K Number: K983792 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    54
    Applicant Total
    8
    Review Days
    45

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
    K Number
    K983792
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Seare Biomedical Corp.
    Date Received
    October 27, 1998
    Decision Date
    December 11, 1998
    Product Code
    LCJ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCJ Tissue Expander And Accessories

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LCJ), ordered by most recent decision date.

    Natrelle 133S Tissue Expanders

    FDA 510(k)
    FDA Unclassified ·Unknown

    MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

    FDA 510(k)
    FDA Unclassified ·Unknown

    Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander

    FDA 510(k)
    FDA Unclassified ·Unknown

    MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander

    FDA 510(k)
    FDA Unclassified ·Unknown

    Motiva Flora SmoothSilk Tissue Expander

    FDA 510(k)
    FDA Unclassified ·Unknown

    AlloX2 Pro Tissue Expanders

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Seare Biomedical Corp.

    K Number Device Name
    K983630 SEARE BIOMEDICAL SILICONE RODS
    K983043 SEARE BIOMEDICAL SILICONE BLOCK
    K982752 SEARE BIOMEDICAL CHIN IMPLANTS
    K982762 SEARE BIOMEDICAL PECTORALIS IMPLANT
    K982753 SEARE BIOMEDICAL NASAL IMPLANTS
    K982763 SEARE BIOMEDICAL MALAR IMPLANTS
    K983041 SEARE BIOMEDICAL SILICONE SHEETING