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    K Number
    K961695
    Device Name
    ENDO-TECH LTD., TIPS
    Manufacturer
    RATIO DESIGN LAB
    Date Cleared
    1996-07-01

    (61 days)

    Product Code
    HFG
    Regulation Number
    884.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    RATIO DESIGN LAB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laparoscopic Unipolar Tips will serve as accessories to the Endo-Tech, Ltd, Inc.,Endo-Aid, which is an Aspiration- Irrigation Device. These tips will thread into the laparoscopic irrigation and aspiration control handle. The tips will be used during laparoscopic procedures and electrosurgical procedures.
    Device Description
    The Laparoscopic Unipolar Tips will be threaded into the Endo-Tech, Ltd., Inc. Endo-Aid (K#930756) and will be used during Laparoscopic procedures. These tips will be used by a range of surgeons for various abdominal procedures in a hospital operating room environment. The Laparoscopic Unipolar Tips consist of the following components: Threaded adapter (Male), Thread on probe and stainless tip (Female:Spatula, L Hook, J Hook, and Needle), Insulation Sheath for Electrosurgical Tips (Ratcheting).
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