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510(k) Data Aggregation

    K Number
    K083556
    Device Name
    MODIFICATION TO AUTO-BAND LIGATOR
    Manufacturer
    SCANDIMED INTERNATIONAL
    Date Cleared
    2009-02-19

    (79 days)

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

    SCANDIMED INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
    Device Description
    The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only modifications being proposed in this current Special 510(k) Premarket Notification are to change the latex formulation of the rubber ligating bands and to expand the product line to include 6 and 8 band variations. The Auto-Band Ligator incorporates the following product features: - Automatic Reverse Movement to START position after each release - Snap Fixation system ensures stable fixation on the scope - Adjustable Snap Fixation System facilitates fixation on all brands of scopes - Precision One-Step Release Mechanism of bands - Only a single band can be released at a time - Latex or Latex Free Rubber Bands - Available in 5, 6, 7, 8 or 10 band configurations
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    K Number
    K081142
    Device Name
    AUTO-BAND LIGATOR
    Manufacturer
    SCANDIMED INTERNATIONAL
    Date Cleared
    2008-05-16

    (24 days)

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

    SCANDIMED INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto Band Ligator is used to band esophageal varices or hemorrhoids in the colon. For single use only.
    Device Description
    The Scandimed Auto-Band Ligator consists of a ligator wheel head mounted on a scope fixation arm and connected by a stainless steel thread to the band barrel. The only change being proposed in this current Special 510(k) Premarket Notification is to convert the original latex rubber ligating bands to latex free rubber ligating bands. The Auto-Band Ligator incorporates the following product features: Automatic Reverse Movement to START position after each release. Snap Fixation system ensures stable fixation on the scope. Adjustable Snap Fixation System facilitates fixation on all brands of scopes. Precision One-Step Release Mechanism of bands. Only a single band can be released at a time. Latex Free Rubber Bands. Available in 5, 7 or 10 band configurations.
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