BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇰🇷 South Korea

    One-Stop

    K Number: K253797 · Decision Feb 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    35
    Applicant Total
    13
    Review Days
    91

    Basic Information

    Device Name
    One-Stop
    K Number
    K253797
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mediclus Co., Ltd.
    Date Received
    November 28, 2025
    Decision Date
    February 27, 2026
    Product Code
    MVL
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MVL Cord, Retraction

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    Other Clearances by Mediclus Co., Ltd.

    K Number Device Name
    K260485 Any-Etch
    K260819 Any-Com Seal
    K253167 Any-Paste
    K252465 Any-Core
    K251884 One-Fil Putty Injectable
    K251283 Once-Fil Flow
    K250823 Any-Com Flow
    K243353 One-Fil Putty
    K242713 Any-Com Bulk
    K241147 Any-Com
    Search all 13 clearances from Mediclus Co., Ltd. →