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510(k) Data Aggregation

    K Number
    K030824
    Device Name
    LAP DISC 120 X 120MM X2CM, MODEL LD111, LAP DISC 120 X 120MMX 7CM,MODEL LD112
    Date Cleared
    2003-06-04

    (82 days)

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

    HAKKO MEDICAL 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, gynecologic 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 membrane. The two lower rings hold the abdominal wall to maintain peritoneal gas pressure. The bottom ring is a flexible ring made with a shapememory 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
    K013108
    Device Name
    BIOSUC
    Date Cleared
    2002-04-04

    (199 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAKKO MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BioSuc Fine Aspiration Cytology Needle is indicated for the biopsy of tumors in the Thyroid, Breast or Lymph node.
    Device Description
    Needle size: 20G: 50mm to 100mm, 21G: 50mm, 22G: 50mm Needle tip: Bayonet point (Lancet point) Suction syringe: 7 ml Plunger slide: 35 mm Side Hole 20G: φ 0.35 to φ 0.5 n=0 to 3; 21G: φ 0.35 to φ 0.5 n=0 to 3; 22G: φ 0.35 n=0 to 2
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    K Number
    K013109
    Device Name
    SONOPSY
    Date Cleared
    2002-03-12

    (176 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAKKO MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Sonopsy aspiration needle is intended to percutaneously obtain abdominal tissue including the liver, prostate, kidney, breast, lymph node, and other soft tissues using ultrasonic visualization.
    Device Description
    Needle size: 14G to 21G, 80 to 200mm Needle tip: Biopsy point Inner needle tip: pencil point or trocar point Suction syringe: 7 ml Plunger slide: 35 mm Guide needle size: L=50 to 80 mm or without Guide needle tip: Lancet point or blunt end Filter paper: size 20x35mm, 3 pieces
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