BEUDAMED
    Product Code: NMR FDA class 2 21 CFR 868.5150

    Needle, Spinal, Short Term, Reprocessed

    Anesthesiology

    The short-term spinal needle (reprocessed) is an anesthesiology device used to deliver spinal or epidural anesthesia by puncturing the dura mater to access the subarachnoid space. It is classified as FDA Class 2 under regulation 868.5150 in the Anesthesiology specialty, requiring 510(k) premarket notification. As a reprocessed single-use device, reprocessing validation data must be included in the 510(k) submission per FDA guidance. Product code NMR is eligible for third-party review.

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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
    NMR
    Device Class
    FDA class 2
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    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).