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

    STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)

    K Number: K952151 · Decision Mar 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    301

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    Basic Information

    Device Name
    STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
    K Number
    K952151
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4100
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Storz
    Date Received
    May 8, 1995
    Decision Date
    March 4, 1996
    Product Code
    HQR
    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
    HQR Apparatus, Cautery, Radiofrequency, Ac-Powered

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