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

    STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE

    K Number: K954340 · Decision Dec 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    6
    Review Days
    87

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    Basic Information

    Device Name
    STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
    K Number
    K954340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Storz
    Date Received
    September 18, 1995
    Decision Date
    December 14, 1995
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Storz

    K Number Device Name
    K960007 STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
    K952151 STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
    K930278 STORZ COMPUSCAN AB
    K926512 STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
    K913504 STORZ MICRO CUTTER 25 GAUGE PACK