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510(k) Data Aggregation

    K Number
    K960347
    Device Name
    SAFETY TROCER WITH SPRINGLOADED OBDURATOR
    Date Cleared
    1996-07-01

    (158 days)

    Product Code
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPIESS DESIGN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Intended Use and the Indications for Use are identical for our SHIELDED Trocar and the other, older Trocar versions.
    Device Description
    Our SHIELDED Trocar adds one feature to the old commonly known Trocar: It does not expose any sharp edges, except when it is pushed through the abdominal wall to gain surgical access. Then, inside of the body cavity, it automatically and immedeately re-entors it's SHIELDING MODE by covering the cutting edge with a springloaded, blunt Obturator. While assembled this new Trocar never allows accidental cutting of a patient or operating room personel. Disassembly of this instrument is only required for cleaning and sterilization. Our SHIELDED Trocar represents a combination between common old Trocars and the SHECRNA function of Veress needles: A springloaded blunt Obturator devic· always covers the sharp cutting edge.
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