BEUDAMED
    Product Code: OIJ FDA class 2 21 CFR 892.1560

    Biopsy Needle Guide Kit

    Radiology

    The Biopsy Needle Guide Kit is a convenience kit containing components used to guide biopsy needles to target lesions under imaging guidance (such as ultrasound or CT), facilitating tissue sampling for pathological analysis. Classified as FDA Class 2 under regulation 21 CFR 892.1560 within the Radiology medical specialty, it has been exempted from the 510(k) premarket notification requirement per FDA Federal Register publication (82 FR 31976, July 11, 2017) and also falls under enforcement discretion per the 1997 Convenience Kits guidance. The product code is OIJ. It is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    30
    Registration Numbers
    30
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    OIJ
    Device Class
    FDA class 2
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Review Panel
    RA
    Submission Type
    4

    Device Characteristics

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

    Definition

    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https://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 30 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.