BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    GONGDONG DISPOSABLE VAGINAL SPECULUM

    K Number: K050887 · Decision Jul 11, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    2
    Review Days
    95

    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
    GONGDONG DISPOSABLE VAGINAL SPECULUM
    K Number
    K050887
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zhejiang Gongdong Medical Plastic Factory
    Date Received
    April 7, 2005
    Decision Date
    July 11, 2005
    Product Code
    HIB
    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
    HIB Speculum, Vaginal, Nonmetal

    Similar 510(k) Clearances

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

    JFord Speculum Sleeve™

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

    BRELLA-SPEC(TM) VAGINAL SPECULUM

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

    IOB DISPOSABLE SPECULUM

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

    CLEARSPEC SINGLE USE VAGINAL SPECULUM

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

    SPECULUM, VAGINAL, NONMETAL

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

    KOLPLUX SYSTEM

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

    Other Clearances by Zhejiang Gongdong Medical Plastic Factory

    K Number Device Name
    K082042 GONGDONG DISPOSABLE SHARP CONTAINER