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510(k) Data Aggregation

    K Number
    K990785
    Device Name
    TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS
    Date Cleared
    1999-08-27

    (171 days)

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

    JAKOUBEK MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Providing thorough irrigation and aspiration of the peritoneal cavity.Bleeders can be identified,bile,stones,tissue,blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry. Sole purpose of these instruments are to move tissue around. Sole purpose of these instrain by means of grasping any body They can not grasp or restrain by addints the body cavity They can not grasp of resorain by de into the body cavity organ or tissue. They are introduced they can only move through a brood trough the or up and down. Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct the introduction and/or dissecting, cutting, repairing, removal observation and/or internal tissues and/or organs. Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said direct of internal tissues or organs may be visualized for either diagnostic or operative procedures. Verres needles puncture through the abdominal wall to enable verres needies puncture theabdominal cavity creating space the introduction of gacce insternal body organs, allowing for the sa between the rabora and the scopic instrumentation into the peritoneal cavity. Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired. Instruments which permit the grasping and manipulation of the country the countancel covity enableing a surgeon Instruments which the pritoneal cavity enableing a surgeon needles inside the peritoneal cavity enableing a surgeon needles inside the periconeal cavily charoscopic procedures. Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy,cut,coagulate,manipulate or retrieve internal biopby, a your while performing laparoscopic procedures.
    Device Description
    Trocar and Trocar Sleeves, Laparoscopes, Laparoscopic Forceps and Laparoscopic Instruments, FAN RETRACTORS AND FINGER DISSECTORS, TROCARS, TROCAR SLEEVES AND DILATORS, VERRES NEEDLES, KNOT PUSHER, NEEDLE HOLDERS, MONOPOLAR ELECTRODES,CAUTERY FORCERS,BIPOLAR FORCEPS & SCISSORS AND NON-CAUTERY FORCEPS
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