BEUDAMED
    Product Code: KAG FDA class 1 21 CFR 878.1800

    Holder, Speculum, Ent

    General, Plastic Surgery

    A speculum holder for ENT use is an accessory instrument designed to hold and stabilize a speculum in position during examination or surgical procedures of the ear, nose, or throat, freeing the clinician's hands. It is classified as an FDA Class 1 device, subject only to general controls, reflecting its low-risk nature and the absence of a premarket notification requirement. Product code KAG is regulated under 21 CFR 878.1800 in the General, Plastic Surgery medical specialty. No special flags apply to this device.

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    510(k)s
    2
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    2
    Years Active
    2

    Basic Information

    Product Code
    KAG
    Device Class
    FDA class 1
    Regulation Number
    878.1800
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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
    K842931 DRABKIN REAGENT
    K822857 CPI PRINTER

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.