BEUDAMED
    Product Code: IDS FDA class 1 21 CFR 864.3010

    Melting Pot, Paraffin

    Pathology

    A paraffin melting pot is a laboratory device used in histopathology to melt solid paraffin wax into a liquid state for tissue infiltration and embedding, forming the solid block from which microtome sections are cut. It is regulated as an FDA Class 1 device, the lowest risk level, subject to general controls without requiring premarket notification. The product code is IDS, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

    Research product code IDS in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    IDS
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K821831 A O HISTOSTAT EMBEDDING CTR #8030,32,34

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.