Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070881
    Device Name
    LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
    Manufacturer
    SAPI MED S.P.A
    Date Cleared
    2007-09-26

    (180 days)

    Product Code
    FHN
    Regulation Number
    876.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAPI MED S.P.A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LEM Hemorrhoidal ligators are used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. Hemorrhoidal ligators are intended for exclusive use by medical personnel trained in proctology procedures.
    Device Description
    The Sapimed LEM Disposable hemorrhoidal ligators are used to apply a ligature or elastic ring around the base of the hemorrhoidal nodule in order to cut off the blood flow to hemorrhoidal tissue. The lack of blood supply will result in shrinkage, desiccation and elimination of the hemorrhoid. It is supplied in two models Model numbers A.5650 and A 5660. They are both manufactured from plastic and designed for single patient use. Both variants are supplied with a separable cylindrical cone (0 10mm) to assist in loading the bands, an angled distal cylinder to contain the nodule, and an ergonomicallydesigned pistol handgrip,with trigger to release the banding ring. The LEM has an angled design that allows the operator a clear view of the procedure.
    Ask a Question

    Page 1 of 1