LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130718
    Device Name
    PEERSCOPE SYSTEM
    Manufacturer
    PEERMEDICAL LTD.
    Date Cleared
    2013-04-16

    (29 days)

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

    PEERMEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PeerScope System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The PeerScope System is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The PeerScope System consists of PeerMedical camera heads, endoscopes, video system, light source and other ancillary equipment.
    Device Description
    The PeerScope system Model H is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. The PeerScope system Model H is a modification of the legally marketed (K 120289) PeerScope system Model B (the predicate device). The system consists of endoscopic Main Control Unit (MCU H) and of the PeerScope CS colonoscope, enabling physicians to view a high resolution wide field of view of up to 300°. The system is labeled for use in healthcare facilities / hospitals for adult patients.
    Ask a Question

    Page 1 of 1