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510(k) Data Aggregation

    K Number
    K102983
    Device Name
    VASCUCLEAR PRECISION BIPOLAR
    Date Cleared
    2010-11-01

    (25 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SORIN GROUP USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VascuClear Precision Bipolar is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of vessels.
    Device Description
    The VascuClear Precision Bipolar is a sterile, bipolar electrosurgical instrument with features to dissect, coagulate, and transect (cut) tissue with an integral knife blade. The device is compatible with a 5mm trocar and utilizes bipolar energy from standard bipolar generators. The instrument consists of three main parts as follows: 1. A handle with two sliding buttons. One button opens and closes the jaw of the device for grasping and clamping. The other button moves the integral knife blade back and forth. A standard pigtail cord is attached to the handle. 2. A shaft that connects the handle to the working end. The shaft is approximately 0.2 inches (5mm) in diameter and 16.5 inches (42cm) long from the handle to the tip of the instrument. 3. The working end of the instrument that consists of jaws, electrode surfaces and an integral knife with a dissecting tip.
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