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510(k) Data Aggregation

    K Number
    K984448
    Device Name
    BIRCOLL BALLOON DISSECTOR
    Manufacturer
    WELLS JOHNSON CO.
    Date Cleared
    1999-01-28

    (45 days)

    Product Code
    FZW,LCJ
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIRCOLL BALLOON DISSECTOR

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

    BREAST RECONSTRUCTION, LIMB RECONSTRUCTION, CORRECTION OF CONGENITAL DEFORMITIES, COSMETIC DEFECTS, SCAR REVISION

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance data for the "Bircoll Balloon Dissector." The documents are FDA 510(k) letters for an administrative change and the original clearance, which primarily discuss regulatory classification, substantial equivalence, and general controls. They do not include the specific technical details of the device's performance or the studies conducted to establish its effectiveness.

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