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510(k) Data Aggregation

    K Number
    K960046
    Device Name
    SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE
    Manufacturer
    SURGICAL DYNAMICS, INC.
    Date Cleared
    1996-04-02

    (91 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL DYNAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is to decompress a herniated lumbar disc using direct visualization during a laparoscopic procedure.
    Device Description
    The Surgical Dynamics 30K Working Channel Scope and Instrument Kit for Laparoscopic Discectomy are comprised of the following components: 30K Working Channel Scope Nucleotome 2.5 mm Laparoscopic Probe Nucleotome 3.5 mm Laparoscopic Probe Nucleotome 4.7 mm Laparoscopic Probe IA Cannula Grasping Forceps with Teeth for Laparoscopic Discectomy The Nucleotome probes are used in conjunction with the Nucleotome console.
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