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510(k) Data Aggregation

    K Number
    K033591
    Device Name
    REPROCESSED TROCARS
    Manufacturer
    CLEAR MEDICAL, INC.
    Date Cleared
    2005-06-03

    (568 days)

    Product Code
    KBG
    Regulation Number
    874.4420
    Why did this record match?
    Product Code :

    KBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.
    Device Description
    Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.
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    K Number
    K013987
    Device Name
    REPROCESSED DISPOSABLE TROCARS
    Manufacturer
    ADVEN MEDICAL
    Date Cleared
    2002-03-01

    (87 days)

    Product Code
    KBG
    Regulation Number
    874.4420
    Why did this record match?
    Product Code :

    KBG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecological or other minimally invasive surgical procedures. Trocars are single patient used devices.
    Device Description
    AMI intends to market Surgical Trocars that have been reprocessed. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. AMI is a third party reprocessor. If all protocol parameters are met, AMI will reprocess each disposable trocar up to two times. Trocars are sold new by the original manufacture to the hospital uses the trocars, collects them and ships them to AMI for reprocessing. Trocars are reprocessed by AMI as described in our reprocessing protocol Control Document Number 40005 and returned to the hospital to be reused. Trocars that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the trocar is not reprocessed at all) or second reprocessing.
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