BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇹🇼 Taiwan

    Bonvadis®

    K Number: K261638 · Decision Jun 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    30

    Basic Information

    Device Name
    Bonvadis®
    K Number
    K261638
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oneness Biotech Co., Ltd.
    Date Received
    May 18, 2026
    Decision Date
    June 17, 2026
    Product Code
    FRO
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRO Dressing, Wound, Drug

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    Other Clearances by Oneness Biotech Co., Ltd.

    K Number Device Name
    K251093 Bonvadis®