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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇸 Iceland

    Kerecis SurgiBind (50241)

    K Number: K251844 · Decision Jul 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    4
    Applicant Total
    10
    Review Days
    29

    Basic Information

    Device Name
    Kerecis SurgiBind (50241)
    K Number
    K251844
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kerecis Limited
    Date Received
    June 16, 2025
    Decision Date
    July 15, 2025
    Product Code
    OXH
    Advisory Committee
    General, Plastic Surgery
    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
    OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

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    Other Clearances by Kerecis Limited

    K Number Device Name
    K251845 Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
    K243843 Tendon Protect (50242)
    K241080 Kerecis Parvus (50207)
    K213231 Kerecis Silicone
    K202430 Kerecis Reconstruct
    K192612 Kerecis Gingiva Graft
    K190528 MariGen Wound Extra
    K153364 Kerecis SecureMesh
    K132343 MARIGEN WOUND DRESSING