BEUDAMED
    Product Code: NNC FDA class 1 21 CFR 878.4800

    Needle, Aspiration And Needle, Reprocessed

    General, Plastic Surgery

    The aspiration needle and needle set (reprocessed) is a surgical device used to withdraw fluids or tissue from body cavities or lesions through aspiration. It is classified as FDA Class 1 under regulation 878.4800 in the General and Plastic Surgery specialty, requiring general controls but not GMP exempt. Reprocessing validation data must be included in the 510(k) submission for this reprocessed device. Product code NNC is eligible for third-party review.

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    510(k)s
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    FEI Numbers
    0
    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    NNC
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    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

    Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).