BEUDAMED
    Product Code: NMX FDA class 2 21 CFR 876.1075

    Needle And Needle Set, Gastro-Urology, Reprocessed

    Gastroenterology, Urology

    The needle and needle set for gastro-urology (reprocessed) is a combination device used in endoscopic or laparoscopic gastrointestinal and urological procedures for tissue puncture, fluid aspiration, or injection. It is classified as FDA Class 2 under regulation 876.1075 in the Gastroenterology and Urology specialty, requiring 510(k) clearance. Reprocessing validation data must be included in the 510(k) submission for this reprocessed device. Product code NMX 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
    NMX
    Device Class
    FDA class 2
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    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).