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

    SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE

    K Number: K133144 · Decision Mar 19, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    153

    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
    SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE
    K Number
    K133144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Crossbay Medical, Inc.
    Date Received
    October 17, 2013
    Decision Date
    March 19, 2014
    Product Code
    PGK
    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
    PGK Cannula, Injector, Uterine, Endometrial Biopsy

    Similar 510(k) Clearances

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

    SONOHYSTEROGRAPHY BIOPSY DEVICE

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

    Other Clearances by Crossbay Medical, Inc.

    K Number Device Name
    K162064 CrossBay IVF Embryo Transfer Catheter Set
    K142545 SonoFlow Sonohysterography and Sonohysterosalpingography Device