BEUDAMED
    Product Code: NCR FDA class 2 21 CFR 886.4100

    Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered

    Ophthalmic

    The Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered (product code NCR) is a battery-operated electrosurgical cutting device used in ophthalmic procedures. It employs radiofrequency energy to make precise cuts during eye surgery. Regulated under 21 CFR 886.4100, it is an FDA Class 2 device requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. It falls under the Ophthalmic medical specialty and is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    3
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    5

    Basic Information

    Product Code
    NCR
    Device Class
    FDA class 2
    Regulation Number
    886.4100
    Medical Specialty
    Ophthalmic
    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 3 510(k) clearances via K numbers.

    K Number Device Name
    K050933 FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
    K041019 THE FUGO BLADE FOR GLAUCOMA
    K001498 THE FUGO BLADE

    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.