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

    STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR

    K Number: K960007 · Decision Mar 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
    K Number
    K960007
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Storz
    Date Received
    January 2, 1996
    Decision Date
    March 26, 1996
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    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
    MPA Endoilluminator

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    Other Clearances by Storz

    K Number Device Name
    K952151 STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
    K954340 STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
    K930278 STORZ COMPUSCAN AB
    K926512 STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
    K913504 STORZ MICRO CUTTER 25 GAUGE PACK