BEUDAMED
    Product Code: NJU FDA class 2 21 CFR 878.4495

    Suture, Nonabsorbable, Nitinol

    General, Plastic Surgery

    The Nitinol Nonabsorbable Suture is a surgical suture made from nitinol (nickel-titanium alloy) intended for soft tissue approximation during surgical procedures, offering unique superelastic and shape-memory properties compared to conventional nonabsorbable sutures. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJU and regulation 21 CFR 878.4495 in the General and Plastic Surgery specialty. The device is flagged as an implant reflecting its placement within the body, but is not life-sustaining.

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

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    Basic Information

    Product Code
    NJU
    Device Class
    FDA class 2
    Regulation Number
    878.4495
    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

    Soft tissue approximation.

    510(k) Clearance History

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    Related 510(k) Clearances

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

    K Number Device Name
    K023372 NON-BIOABSORBABLE STAPLE
    K023125 COALESCENT U-CLIP- AND ACCESSORIES