BEUDAMED
    Product Code: NWN FDA class 2 21 CFR 888.3040

    Laparoscopic Bone Anchor Urethropexy Instrument Kit

    Orthopedic

    The Laparoscopic Bone Anchor Urethropexy Instrument Kit (product code NWN) is a surgical convenience kit used in laparoscopic urethropexy procedures involving bone anchors, regulated under 21 CFR 888.3040 in the Orthopedic specialty. As a Class 2 convenience kit established under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) if all guidance criteria are met. The device has no implant or life-sustaining designations.

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    510(k)s
    0
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    NWN
    Device Class
    FDA class 2
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    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 http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.