BEUDAMED
    Product Code: NTN FDA class 2 21 CFR 876.1500

    Led Light Source

    Gastroenterology, Urology

    The LED Light Source is a device that provides illumination using light-emitting diode technology to enable access, illumination, and observation or manipulation of body cavities, hollow organs, and canals during endoscopic procedures. It is an FDA Class 2 device regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, with product code NTN, and is exempt from premarket notification under submission type 4. It is not an implant and does not carry life-sustaining support designation.

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    510(k)s
    9
    FEI Numbers
    82
    Registration Numbers
    82
    Unique Applicants
    8
    Years Active
    6

    Basic Information

    Product Code
    NTN
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    4

    Device Characteristics

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

    Definition

    Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K141164 ARTEMIS LIGHT ENGINE
    K133311 ENDOLED
    K130819 CLL- V1 LIGHT SOURCE
    K122831 VIDEO SYSTEM CENTER
    K113679 LUCEA LED SURGICAL LIGHT SYSTEM
    K103813 SOPRO 281
    K102167 LO-50 LED LIGHT SOURCE
    K091829 PLS PORTABLE LIGHT SOURCE
    K090601 FSC 2

    FEI Numbers

    This FDA classification entry is associated with 82 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 82 registration numbers. Click on an entry to view related FDA registrations.