BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GAYHEART CORNEAL EXCISION DEVICE

    K Number: K022843 · Decision Nov 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    123
    Same Product Code
    11
    Applicant Total
    5
    Review Days
    66

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    Basic Information

    Device Name
    GAYHEART CORNEAL EXCISION DEVICE
    K Number
    K022843
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stephens Instruments
    Date Received
    August 27, 2002
    Decision Date
    November 1, 2002
    Product Code
    HRH
    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
    HRH Trephine, Manual, Ophthalmic

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    Other Clearances by Stephens Instruments

    K Number Device Name
    K022840 STEPHENS DISPOSABLE SCISSORS
    K022835 STEPHENS DISPOSABLE FORCEPS
    K022836 STEPHENS DISPOSABLE SPECULUM
    K022842 STEPHENS DISPOSABLE HOOKS