BEUDAMED
    Product Code: NLK FDA class 1 21 CFR 878.4800

    Needle, Biopsy, Cardiovascular, Reprocessed

    General, Plastic Surgery

    The Reprocessed Cardiovascular Biopsy Needle is a reprocessed surgical needle used to obtain tissue biopsy samples from cardiac or vascular structures; reprocessing validation data must be included in a 510(k) submission. It is classified as FDA Class 1 (General Controls), under product code NLK and regulation 21 CFR 878.4800 in the General and Plastic Surgery specialty. The device is eligible for third-party review and is not an implant or life-sustaining device.

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

    Product Code
    NLK
    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).