BEUDAMED
    Product Code: OGE FDA class 2 21 CFR 868.5120

    Epidural Anesthesia Kit

    Anesthesiology

    The Epidural Anesthesia Kit is a convenience kit providing components for administering epidural anesthesia, a widely used technique for surgical anesthesia and labor analgesia involving injection into the epidural space of the spine. It is classified as FDA Class 2 under regulation 21 CFR 868.5120 within the Anesthesiology medical specialty, and is under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, exempting it from 510(k) requirements when all criteria are met. The product code is OGE. It is not designated as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    35
    Registration Numbers
    35
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OGE
    Device Class
    FDA class 2
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

    FEI Numbers

    This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.