BEUDAMED
    Product Code: HNK FDA class 1 21 CFR 886.4350

    Probe, Trabeculotomy

    Ophthalmic

    A Trabeculotomy Probe is a surgical instrument used in glaucoma procedures to open the trabecular meshwork and improve aqueous drainage from the eye, thereby reducing intraocular pressure. This device is FDA Class 1 (lowest risk), subject only to general controls and not requiring premarket notification or approval. It carries product code HNK and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

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    510(k)s
    0
    FEI Numbers
    38
    Registration Numbers
    38
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HNK
    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

    FEI Numbers

    This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.