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

    ECHOSAMPLER

    K Number: K041237 · Decision Sep 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    4
    Applicant Total
    4
    Review Days
    120

    Basic Information

    Device Name
    ECHOSAMPLER
    K Number
    K041237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1060
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    GYNETICS MEDICAL PRODUCTS NV
    Date Received
    May 11, 2004
    Decision Date
    September 8, 2004
    Product Code
    HFF
    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
    HFF Aspirator, Endometrial

    Similar 510(k) Clearances

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

    PROBET (TM)

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

    WALLACH FLEXIBLE ENDOMETRIAL SAMPLER

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

    ENDOSCANN

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

    ACCURETTE

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

    Other Clearances by GYNETICS MEDICAL PRODUCTS NV

    K Number Device Name
    K013501 IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
    K013536 EMTRAC; DELPHIN; SEMTRAC 2000 SET
    K013497 FAS SET #4551