BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇨🇳 China

    Roosin Collagen Powder

    K Number: K254034 · Decision Jun 3, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    169

    Basic Information

    Device Name
    Roosin Collagen Powder
    K Number
    K254034
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roosin Medical Co., Ltd.
    Date Received
    December 16, 2025
    Decision Date
    June 3, 2026
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

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    Other Clearances by Roosin Medical Co., Ltd.

    K Number Device Name
    K253974 Roosin Collagen Dressing
    K231088 Copper Foam Dressing (Prescription and OTC)
    K230190 Polyver Silver Alginate Dressing (Prescription and OTC)
    K181478 Roosin Xeroform Petrolatum Dressing