BEUDAMED
    Product Code: IDL FDA class 1 21 CFR 864.3010

    Microtome, Accessories

    Pathology

    Microtome accessories are supplementary components used with tissue-sectioning instruments in pathology laboratories, including items such as blades, blade holders, specimen holders, and anti-roll plates that support the preparation of thin tissue sections for microscopic examination. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IDL, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    5
    FEI Numbers
    39
    Registration Numbers
    39
    Unique Applicants
    4
    Years Active
    6

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    Basic Information

    Product Code
    IDL
    Device Class
    FDA class 1
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Review Panel
    PA
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K863616 KNIFE MAKER
    K831921 DISPOSABLE MICROTOME BLADES
    K831308 DISPOSABLE MICROTOME BLADE
    K813430 TISSUE PROCESSING CASSETTES & ACCESS
    K801426 TISSUE-TEK III MICROJECT DISP. BLADE SYS

    FEI Numbers

    This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.