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

    CROAK OVARIAN BIOPSY FORCEP

    K Number: K902049 · Decision Jun 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    21
    Applicant Total
    9
    Review Days
    31

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    Basic Information

    Device Name
    CROAK OVARIAN BIOPSY FORCEP
    K Number
    K902049
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Gynescope Corp.
    Date Received
    May 7, 1990
    Decision Date
    June 7, 1990
    Product Code
    HFB
    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
    HFB Forceps, Biopsy, Gynecological

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    Other Clearances by Gynescope Corp.

    K Number Device Name
    K902657 GYNESCOPE LAPAROSCOPIC FORCEPS
    K902658 GYNESCOPE MONOPOLAR FORCEPS AND ELECTRODES
    K901530 WALLACE INTRAUTERINE INSEMINATION CATHETER
    K902655 GYNESCOPE LAPAROSCOPES
    K902656 GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES
    K902019 MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
    K900878 OTT INSUFFLATION FILTER TUBING
    K895225 GYNECOLOGICAL INSTRUMENTATION