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510(k) Data Aggregation

    K Number
    K031238
    Device Name
    VARICES NEEDLE
    Manufacturer
    SCANDIMED. A.S.
    Date Cleared
    2004-10-04

    (535 days)

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

    SCANDIMED. A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Varices Needle is used to inject sclerotherapy agent into varices in the esophagus and colon, via an endoscope using direct visualization. The Varices Needle is intended for single use only.
    Device Description
    Not Found
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    K Number
    K031236
    Device Name
    AUTO-BAND LIGATOR
    Manufacturer
    SCANDIMED. A.S.
    Date Cleared
    2003-11-14

    (210 days)

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

    SCANDIMED. A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auto-Band Ligator are used to band esophageal varices or haemorrhoids in the colon. For single use only.
    Device Description
    Not Found
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