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510(k) Data Aggregation

    K Number
    K070915
    Device Name
    SAPIMED DISPOSABLE SIGMOIDOSCOPE
    Manufacturer
    SAPIMED S.P.A.
    Date Cleared
    2007-07-06

    (95 days)

    Product Code
    KDM, KOG
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    KDM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SAPIMED's Sigmoidoscopes are used to examine the rectum and lower bowel and, using additional accessories, perform various diagnostic and/or therapeutic procedures.
    Device Description
    The Proctoscopy set consists of a multi-use plastic Grip (Ref. A.4131) and a choice of 3 different single use Insertion Tubes (Ref. A.4113, A.4120, A.4125). Each insertion tube comes with a matching obturator to facilitate the atraumatic insertion of the tube into the rectum. The multi-use plastic Grip (Ref. A.4131) consists of the following elements: 1. A hollow handle designed to connect to the light source (either a fiberoptic cable or a pen-light). 2. A circular frontal opening designed to connect to the Insertion Tube. 3. A posterior hinged closure containing both the lens and the insufflator attachment. The insufflator is a hand squeeze ball with a one-way valve as also used in manual blood pressure measuring devices. The Sigmoidoscope Kit MRP (ref. A.4522) consists of a Rigid Proctosigmoidoscope insertion tube and a plastic grip.
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