LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032242
    Device Name
    PERSONNA PLUS SAFETY SCALPEL SYSTEM
    Manufacturer
    OMI MANUFACTURING PTY., LTD.
    Date Cleared
    2003-09-23

    (64 days)

    Product Code
    GESGDZ
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PersonnaPlus Safety Scalpel System is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.
    Device Description
    The device is a combination scalpel blade and handle incorporating a sharps injury protection feature. There are two product options -(1) a totally disposable unit and (2) a metal handle with disposable blade and guard - our "reposable" product. The totally disposable unit uses a plastic handle while the reposable product has a stainless steel handle.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1