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510(k) Data Aggregation

    K Number
    K070913
    Device Name
    SELF-LIGHT DISPOSABLE ANOSCOPE
    Manufacturer
    SAPIMED S.P.A.
    Date Cleared
    2007-08-10

    (130 days)

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

    SAPIMED S.P.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sapimed Self Ligh®t Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    The Sapimed Self Light ® Disposable Anoscopes are clear, transparent plastic anoscopes in a range of sizes to suit varying clinical needs. Illumination is provided by either coldlight source GLF 100 or pen-light. The anoscopes are provided in the following configurations: Models A.4018 and 4019 are clear anscopes for a clear and easy rectal examination. Models A.4023 and 4024 are anoscopes for examination and use in surgical procedures. The Self-Light® Disposable Operating Anoscopes are clear, transparent disposable anoscopes for various proctological procedures. Illumination is provided by either coldlight source GLF 100 or pen-light. Model A.4081 is an operating anoscopes with a curved shape, transparency and length suitable for open and close hemorrhoiectomy, spincterotomy , coleo/ileo anastamosis, anoplasty, etc. Model A.4082 Basile's cone shaped operating anoscope has a graduated scale visible on the internal part of the instrument. ModelA.4083 The Beak is a surgical anoscope with a closed and rounded tip and a fulllength open channel 2-2.5cm wide
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    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?
    Applicant Name (Manufacturer) :

    SAPIMED S.P.A.

    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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