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510(k) Data Aggregation

    K Number
    K983538
    Device Name
    MINIATURIZED BIOPSY,SCOPE A.K.A: BIOPSY NEEDLE WITH ENDOSCOPIC VIEWING CAPABILITY
    Manufacturer
    SOLOS ENDOSCOPY, INC.
    Date Cleared
    1998-11-06

    (28 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLOS ENDOSCOPY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use for visualization inside the human body to view surgical procedure(s), by physician. The Indications for this device use is when medical practitioner needs visualization in order to view surgical procedures, gaining access either through a natural orifice or incision.
    Device Description
    The design of SOLOS ENDOSCOPY made/marketed endoscopes K971996, K926166 is virtually the same as soopes approved for intended use for the purpose of visualization of surgical procedures.
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