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

    GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES

    K Number: K902656 · Decision Jun 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    GYNESCOPE LAPAROSCOPIC TROCARS AND SLEEVES
    K Number
    K902656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Gynescope Corp.
    Date Received
    June 15, 1990
    Decision Date
    June 29, 1990
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

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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
    K902019 MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS
    K902049 CROAK OVARIAN BIOPSY FORCEP
    K900878 OTT INSUFFLATION FILTER TUBING
    K895225 GYNECOLOGICAL INSTRUMENTATION