BEUDAMED
    Product Code: NVH FDA class 2 21 CFR 878.4300

    Suture, Knot, Mechanical

    General, Plastic Surgery

    The Mechanical Knot Suture is a surgical device used for the approximation and/or ligation of soft tissue during surgical procedures, providing an alternative to hand-tied surgical knots. The mechanical knotting mechanism facilitates consistent, secure closure of tissue. It is an FDA Class 2 implant regulated under 21 CFR 878.4300 in the General and Plastic Surgery specialty, with product code NVH, requiring 510(k) clearance. The implant flag is set reflecting its placement within tissue during surgery. It does not carry life-sustaining support designation.

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

    Research product code NVH 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
    NVH
    Device Class
    FDA class 2
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    In approximation and/or ligation of soft tissue

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K051488 MEDICINELODGE ZIPKNOT