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510(k) Data Aggregation

    K Number
    K012198
    Device Name
    GIBBONS STERILE TROCAR KITS
    Manufacturer
    GIBBONS SURGICAL CORP.
    Date Cleared
    2001-08-09

    (27 days)

    Product Code
    FBQ
    Regulation Number
    876.5090
    Why did this record match?
    Product Code :

    FBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gibbons' Surgical Corporation Sterile Trocar Kits contain devices intended for use during laparoscopic/ endoscopic surgery under the guidance of a physician.
    Device Description
    Not Found
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    K Number
    K980804
    Device Name
    SABRE BT BLUNT0TIP SURGICAL TROCAR
    Manufacturer
    ENDOSCOPIC CONCEPTS, INC.
    Date Cleared
    1998-04-01

    (30 days)

    Product Code
    FBQ
    Regulation Number
    876.5090
    Why did this record match?
    Product Code :

    FBQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECI Sabre BT™ Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and permit maintenance of insufflation.
    Device Description
    The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non-threaded), plastic cannula which is available with an inner diameter of 5, 10 or 12mm. The blunttipped trocar is a multi-piece assembly consisting of a plastic handle, and a smooth, rounded plastic tip. This device is intended for use in laparoscopic procedures where the initial incision has been made surgically. The trocar's blunt, atraumatic tip gently moves aside the internal viscera when the device is inserted through the incision site. Because the OD of the cannula is non-threaded, the device is supplied with an adjustable plug or "olive" which is secured to the patient's skin using sutures placed through the device's "tie posts." The olive has a silicone inner lock ring which firmly grasps the cannula OD when the device is manually tightened.
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