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

    EASY-SPEC

    K Number: K790853 · Decision Jul 30, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    7
    Review Days
    87

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EASY-SPEC
    K Number
    K790853
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    C. Intl.
    Date Received
    May 4, 1979
    Decision Date
    July 30, 1979
    Product Code
    KNA
    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
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNA), ordered by most recent decision date.

    PANPAC WORD/BARTHOLIN CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by C. Intl.

    K Number Device Name
    K792494 CATHETERIZATION FORCEP
    K790855 SURGICAL DRAPE CLIP #201
    K790852 VAGI-SPEC
    K790851 VAGI-PRESS #401
    K790854 FORCEPS #101 AND #102
    K790856 PROCTOSCOPE #501