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

    OAC (OPTICAL ASPIRATING CURETTE)

    K Number: K980096 · Decision May 1, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    112

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    Basic Information

    Device Name
    OAC (OPTICAL ASPIRATING CURETTE)
    K Number
    K980096
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imagyn Medical Technologies, Inc.
    Date Received
    January 9, 1998
    Decision Date
    May 1, 1998
    Product Code
    HCY
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HCY Curette, Uterine

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