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

    RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)

    K Number: K093508 · Decision Mar 4, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    112

    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
    RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
    K Number
    K093508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5070
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Womancare Global
    Date Received
    November 12, 2009
    Decision Date
    March 4, 2010
    Product Code
    HGH
    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
    HGH Cannula, Suction, Uterine

    Similar 510(k) Clearances

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

    Hysteroscopy System

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

    PANPAC DISPOSABLE VACUUM CURETTES

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

    DISPOSABLE ENDOSCOPIC CANNULA

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

    KOLSTER METHODS

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

    NON STRESS TEST MONITOR 507

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