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

    KRONNER MANIPUJECTOR

    K Number: K904473 · Decision Dec 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    10
    Review Days
    74

    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
    KRONNER MANIPUJECTOR
    K Number
    K904473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Unimar, Inc.
    Date Received
    October 1, 1990
    Decision Date
    December 14, 1990
    Product Code
    HES
    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
    HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

    Similar 510(k) Clearances

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

    KAHN UTERINE CANNULA, JARCHO UTERINE CANNULA, NEAL FALLOPIAN CANNULA

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

    HYSTALOG HSG CATHETER

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

    MAXI-FLOW INSUFFLATOR TUBING SET W/FILTER

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

    MAXI-FLOW INSUFFLATOR TUBING SET

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

    CORE DISPOSABLE INSUFFLATION TUBING

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

    SHOLKOFF BALLOON HYSTEROSALPINGOGRAPHY CATHETER

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

    Other Clearances by Unimar, Inc.

    K Number Device Name
    K932432 KRONNER REINFORCING STYLETTE
    K920803 HSG TRAY
    K910317 UNI-SEM(TM)
    K895659 HUI MINI-FLEX
    K895403 ASPIRETTE ENDOCERVICAL ASPIRATOR
    K894264 KDF-2.3
    K890848 CERVEX-BRUSH
    K854415 ENDOMETRIAL PIPELLE
    K810291 STERILE/DISPOSABLE HSG TRAY