BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLARUS ENDOSCOPIC HOOK KNIFE

    K Number: K925741 · Decision Aug 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    22
    Review Days
    284

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    Basic Information

    Device Name
    CLARUS ENDOSCOPIC HOOK KNIFE
    K Number
    K925741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1630
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clarus Medical Systems, Inc.
    Date Received
    November 13, 1992
    Decision Date
    August 24, 1993
    Product Code
    HLX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HLX Photostimulator, Ac-Powered

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