BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SINGLE CHANNEL BALLOON CANNULA

    K Number: K974801 · Decision Jul 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    199

    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
    SINGLE CHANNEL BALLOON CANNULA
    K Number
    K974801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Conkin Surgical Instruments , Ltd.
    Date Received
    December 22, 1997
    Decision Date
    July 9, 1998
    Product Code
    HDP
    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
    HDP Elevator, Uterine

    Similar 510(k) Clearances

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

    COLPO CUP CVC-2000

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

    HYSTERO KIT

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

    HASSON BUEC-3

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