BEUDAMED
    Product Code: MTW FDA class 2 21 CFR 884.6170

    System, Water, Reproduction, Assisted, And Purification

    Obstetrics/Gynecology

    An Assisted Reproduction Water System and Purification device is used to produce and maintain ultra-pure water meeting the stringent quality requirements for use in assisted reproductive technology (ART) laboratory procedures such as in vitro fertilization (IVF), where water purity directly impacts embryo viability. It is FDA Class 2, requiring 510(k) clearance, with product code MTW under 21 CFR 884.6170 in the Obstetrics/Gynecology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    1

    Research product code MTW in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    MTW
    Device Class
    FDA class 2
    Regulation Number
    884.6170
    Medical Specialty
    Obstetrics/Gynecology
    Review Panel
    OB
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K011598 WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE
    K993140 WATER FOR TISSUE CULTURE, MODELS 1500