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

    ENDOCERVICAL ASPIRATOR

    K Number: K812175 · Decision Sep 21, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    49

    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
    ENDOCERVICAL ASPIRATOR
    K Number
    K812175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1050
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Fertility Instrumentation, Inc.
    Date Received
    August 3, 1981
    Decision Date
    September 21, 1981
    Product Code
    HFC
    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
    HFC Aspirator, Endocervical

    Similar 510(k) Clearances

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

    ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR

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

    CERVICAL MUCOUS ASPIRATION CATHETER

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

    PEDI VAGINAL ASPIRATOR

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

    SELECTMUCUS

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

    ENDOCERVICAL ASPIRATOR

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

    O. B. PACK IV

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