BEUDAMED
    Product Code: PBY FDA class 2 21 CFR 878.4300

    Temporary Tissue Marker

    General, Plastic Surgery

    The Temporary Tissue Marker is a surgical device intended to temporarily mark a tissue site for surgical removal for up to 30 days; the marker is removed along with the target tissue during the surgical procedure. It falls under the General and Plastic Surgery medical specialty and is classified as a Class 2 device under regulation 878.4300, requiring 510(k) premarket notification. These devices are used in procedures such as cancer lumpectomies or lesion removal to guide surgeons to the correct site. It is not an implant and is not life-sustaining.

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    510(k)s
    7
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    5
    Years Active
    11

    Basic Information

    Product Code
    PBY
    Device Class
    FDA class 2
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K223682 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    K222643 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    K200734 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    K163667 RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack)
    K163541 Magseed Magnetic Marker System
    K153044 Sentimag System, Sentimark Magnetic Marker Systerm
    K120804 CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.