BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    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)

    K Number: K243722 · Decision Apr 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    126

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    Basic Information

    Device Name
    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)
    K Number
    K243722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4755
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Selio Medical Limited
    Date Received
    December 3, 2024
    Decision Date
    April 8, 2025
    Product Code
    OMT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OMT Absorbable Lung Biopsy Plug

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