LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992288
    Device Name
    AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
    Manufacturer
    TYCO INTL. (US), INC.
    Date Cleared
    1999-07-30

    (23 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TYCO INTL. (US), INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Auto Suture* Soft Thoracoport* obturator and sleeve is indicated for use in establishing a port of entry for endoscopic instruments (straight and curved) in thoracic and other procedures, where insufflation is not required.
    Device Description
    The Auto Suture* Soft Thoracoport** obturator and sleeve consists of a sterile, single-use, blunt-tipped obturator and a flexible threaded sleeve. The threaded sleeve has a shroud at its proximal end to protect against foreign materials entering the cavity and for instrument stabilization. The Auto Suture* Soft Thoracoport** obturator and sleeve is available in 5mm, 12mm and 15mm sizes.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1