BEUDAMED
    Product Code: OMT FDA class 2 21 CFR 878.4755

    Absorbable Lung Biopsy Plug

    General, Plastic Surgery

    The Absorbable Lung Biopsy Plug (product code OMT) is a Class 2 implantable surgical device regulated under 21 CFR 878.4755 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is a pre-formed polymerized absorbable plug intended to mark a biopsy location for visualization during surgical resection and to close pleural punctures associated with percutaneous transthoracic needle lung biopsies, expanding within the biopsy tract until it is resorbed. The device is flagged as an implant and is not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    2
    Years Active
    12

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    Basic Information

    Product Code
    OMT
    Device Class
    FDA class 2
    Regulation Number
    878.4755
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    Definition

    A pre-formed (polymerized) absorbable lung biopsy plug is intended to provide accuracy in marking a biopsy location for visualization during surgical resection and closure of pleural punctures associated with percutaneous, transthoracic needle lung biopsies. Upon, deployment into the biopsy tract, the plug expands to fill the biopsy void and remains in place until resorbed.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K243722 Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003)
    DEN090007 BIO-SEAL LUNG BIOPSY TRACT SYSTEM

    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.