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

    SHAPIRO CUTTER

    K Number: K890544 · Decision Feb 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    5
    Review Days
    25

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    Basic Information

    Device Name
    SHAPIRO CUTTER
    K Number
    K890544
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    H.S. Intl. Co., Inc.
    Date Received
    February 3, 1989
    Decision Date
    February 28, 1989
    Product Code
    HQE
    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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    Other Clearances by H.S. Intl. Co., Inc.

    K Number Device Name
    K973197 FIRE STICK
    K951905 SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE
    K950852 CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
    K925850 DISPOSABLE UNIVERSAL LAPORASCOPIC SCISSORS