BEUDAMED
    Product Code: HNX FDA class 1 21 CFR 886.4350

    Depressor, Orbital

    Ophthalmic

    An Orbital Depressor is a manual ophthalmic surgical instrument used to displace or indent the globe or periorbital structures, allowing the surgeon to visualize or access the peripheral retina and posterior eye segment during examination or surgery. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification or approval. It carries product code HNX and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

    View on FDA
    510(k)s
    2
    FEI Numbers
    85
    Registration Numbers
    85
    Unique Applicants
    1
    Years Active
    0

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    Basic Information

    Product Code
    HNX
    Device Class
    FDA class 1
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K951702 FMS HIGH FLOW ARTHRO-SHEATH
    K951701 FMS ARTHRO-CUTTER

    FEI Numbers

    This FDA classification entry is associated with 85 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 85 registration numbers. Click on an entry to view related FDA registrations.