BEUDAMED
    Product Code: PFU FDA not classified

    Tissue Processing Kit

    Unknown

    The Tissue Processing Kit is a device intended for the preparation of human tissue specimens for frozen sectioning and histological examination. It is classified as "Not Classified" (Class N) by the FDA, meaning it has not been assigned to a formal classification category and may be subject to ongoing regulatory determination. The product code is PFU, reviewed by the Pathology (PA) panel, with no regulation number or medical specialty formally assigned. This device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PFU
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    PA
    Submission Type
    7

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    For the preparation of human tissue specimens for frozen sectioning and histological examination.

    Unclassified Reason

    6

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.