BEUDAMED
    Product Code: NWB FDA class 2 21 CFR 876.1500

    Endoscope, Accessories, Narrow Band Spectrum

    Gastroenterology, Urology

    The Narrow Band Spectrum Endoscope Accessories device provides an alternative mode of endoscopic visualization using narrow spectral bands of visible light for illumination, enhancing contrast of mucosal surfaces during endoscopy and endoscopic surgery of the upper and lower digestive tract and urinary tract. This technology improves detection of vascular patterns and superficial mucosal lesions. It is an FDA Class 2 device regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty, with product code NWB, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.

    View on FDA
    510(k)s
    9
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    4
    Years Active
    17

    Research product code NWB in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    NWB
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

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

    Definition

    Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

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

    K Number Device Name
    K222020 HD-550 Video Endoscope System
    K211882 HD-550 Video Endoscope System
    K173921 HD-500 Video Endoscope System
    K133538 VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE
    K100584 EVIS EXERAII 180 SYSTEM
    K090980 HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
    K072957 EVIS EXERA II 180 SYSTEM
    K062049 EVIS EXERA II 180 SYSTEM
    K051645 EVIS EXERA 160A SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.