BEUDAMED
    Product Code: LXK FDA class 1 21 CFR 878.4800

    Scrapper, Skin Specimen

    General, Plastic Surgery

    The Skin Specimen Scraper (product code LXK) is a simple surgical instrument used to collect skin specimens by scraping the surface of skin lesions for laboratory examination or diagnostic purposes. Regulated under 21 CFR 878.4800 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty. It is not an implant, is not life-sustaining, and is not GMP-exempt.

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    510(k)s
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LXK
    Device Class
    FDA class 1
    Regulation Number
    878.4800
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K881151 MICROSCRAPE

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.