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510(k) Data Aggregation

    K Number
    K963813
    Device Name
    SURE CORE BIOPSY KIT
    Manufacturer
    INTERVENTIONAL CONCEPTS, INC.
    Date Cleared
    1997-03-20

    (178 days)

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

    INTERVENTIONAL CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    for the intended purpose of obtaining soft tissue core biopsy samples.
    Device Description
    The Sure-Core Biopsy Electrode Kit consists of four components: a locator needle, a locator wire, a soft tissue dillator, and the Sure-Core electrosurgical core cutting electrode. The Sure Core Biopsy Electrode is both a manual core cutting device and a monopolar electrosurgical device that is used to cut soft tissue for the purpose of obtain a biopsy sample. The distal tip is a sharp stainless steel cutting blade which cores the tissue distal to the end of the dilator. The most difficult aspect of obtaining a true core biopsy is the detachment of the core from the remaining tissue. The Sure-Core Biopey Electrode overcomes this obstacle by means of a monopolar electrosurgical wire. The electrosurgical wire cuts the tissue perpendicular to the distal blade.
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