BEUDAMED
    Product Code: KAT FDA class 1 21 CFR 874.4420

    Perforator, Antrum

    Ear, Nose, Throat

    An antrum perforator is a pointed surgical instrument used in otolaryngology to puncture the wall of the maxillary sinus (antrum) for diagnostic or therapeutic purposes, such as irrigation or drainage of sinus contents. It is classified as an FDA Class 1 device, the lowest risk tier, subject only to general controls without requiring premarket notification. Product code KAT is regulated under 21 CFR 874.4420 in the Ear, Nose, Throat medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    18
    Registration Numbers
    18
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    KAT
    Device Class
    FDA class 1
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    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 18 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.