BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇮🇸 Iceland

    Kerecis Silicone

    K Number: K213231 · Decision Jun 29, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    10
    Review Days
    272

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    Basic Information

    Device Name
    Kerecis Silicone
    K Number
    K213231
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kerecis Limited
    Date Received
    September 30, 2021
    Decision Date
    June 29, 2022
    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 Kerecis Limited

    K Number Device Name
    K251845 Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus
    K251844 Kerecis SurgiBind (50241)
    K243843 Tendon Protect (50242)
    K241080 Kerecis Parvus (50207)
    K202430 Kerecis Reconstruct
    K192612 Kerecis Gingiva Graft
    K190528 MariGen Wound Extra
    K153364 Kerecis SecureMesh
    K132343 MARIGEN WOUND DRESSING