BEUDAMED
    Product Code: KYH FDA class 2 21 CFR 876.1500

    Endoscope, Ophthalmic

    Gastroenterology, Urology

    The Ophthalmic Endoscope is a minimally invasive optical instrument designed to enable direct visualization of intraocular structures during ophthalmic surgical procedures, providing magnified imagery to guide surgical interventions within the eye. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KYH, regulated under 21 CFR 876.1500, in the Gastroenterology, Urology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

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

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K941660 GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.