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510(k) Data Aggregation

    K Number
    K020307
    Device Name
    LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
    Date Cleared
    2002-04-26

    (87 days)

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

    HAKKO SHOJI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LAP DISC Hand Access Device is intended to provide extracorporeal extension of pneumoperitoneum and abdominal access for the surgeon during laparoscopic surgery. The LAP DISC is indicated for use in laparoscopic procedures, where entry of the surgeon's hand may facilitate the procedure, and for extraction of large specimens. The LAP DISC has application in colorectal, urological and general surgical procedures. This indication for use includes the specific procedures which fall under these broad categories.
    Device Description
    The LAP DISC is a sterile, single-use disposable device. The LAP DISC is an abdominal wall closure unit consisting of three overlaid plastic rings that are interconnected by means of a silicone rubber. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shape-memory alloy. The top ring has a structure similar to the aperture in a camera (an Iris Valve). Because the aperture of the Iris Valve can be adjusted continuously, the system can maintain constant peritoneal gas pressure while allowing the insertion of the surgeon's hand and alternatively, it can be used as an insertion site.
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    K Number
    K961151
    Device Name
    SPINAL NEEDLES
    Date Cleared
    1997-03-19

    (362 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAKKO SHOJI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K961152
    Device Name
    TUOHY EPIDURAL NEEDLES
    Date Cleared
    1997-03-19

    (362 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAKKO SHOJI CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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