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

    INTRAUTERINE SOUND, PLASTIC DISPOSABLE

    K Number: K760170 · Decision Jul 19, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    9
    Applicant Total
    56
    Review Days
    13

    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
    INTRAUTERINE SOUND, PLASTIC DISPOSABLE
    K Number
    K760170
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    July 6, 1976
    Decision Date
    July 19, 1976
    Product Code
    HHM
    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
    HHM Sound, Uterine

    Similar 510(k) Clearances

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

    CERVILENZ UTERINE MEASURING SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    INTRAUTERINE SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ROCKET INTRAUTERINE DEPTH SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    ROCKET INTRAUTERINE SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    TEFLON UTERINE SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    UTERINE SOUND

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology
    View all

    Other Clearances by G.D. Searle and Co.

    K Number Device Name
    K821159 IN-LINE OXYGEN MONITORING SYSTEM
    K811068 BYPASS COIL
    K811071 VENOUS OXYGEN PROBE
    K803238 INTRAVASCULAR CATHETER
    K810630 SILICONE ELASTOMER COATED LATEX FOLEY
    K810131 ADMINISTRATION SET
    K802485 SEARLE VASCULAR LOOPS
    K801805 METRONIDAZOLE DISCS
    K810112 SWR DISPOSABLE PREP RAZOR
    K802213 WHITE KNIGHT BOVIE CORD/SUCTION TUBE
    Search all 56 clearances from G.D. Searle and Co. →