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510(k) Data Aggregation

    K Number
    K153472
    Device Name
    Quiver Laparoscopic Extendable
    Manufacturer
    ITL Corporation PTY LTD
    Date Cleared
    2016-06-23

    (204 days)

    Product Code
    HAM
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    HAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Holder for electrosurqical diathermy system conducting unit and/or other long instruments during surgery. For single use only.
    Device Description
    The Quiver Laparoscopic Extendable is a telescoping instrument holder comprised of two separate parts. One component (the outer or top component) has two open ends and the other component has one open end and one closed end. It is provided assembled and sterile, allowing compact storage and shipment then extension by the user to hold long surgical instruments. After use, the device can be collapsed for compact disposal. A loop handle attached to the top can be used for hanging the device in a convenient place.
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    K Number
    K000079
    Device Name
    NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M
    Manufacturer
    NIKOMED U.S.A., INC.
    Date Cleared
    2000-02-04

    (24 days)

    Product Code
    HAM
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    HAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993306
    Device Name
    NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
    Manufacturer
    PALADIN MEDICAL, INC.
    Date Cleared
    1999-11-03

    (30 days)

    Product Code
    HAM, GEI
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    HAM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
    Device Description
    The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
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