BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Miromatrix Biological Mesh

    K Number: K160400 · Decision Jun 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    117

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Miromatrix Biological Mesh
    K Number
    K160400
    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
    Miromatrix Medical, Inc.
    Date Received
    February 12, 2016
    Decision Date
    June 8, 2016
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OXH), ordered by most recent decision date.

    Kerecis SurgiBind (50241)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Kerecis Reconstruct

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SurgiMend PRS Meshed, Revize-X

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Miromatrix Biological Mesh RS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Miromatrix Medical, Inc.

    K Number Device Name
    K162570 Miromatrix Biological Mesh TW
    K150341 Miromatrix Biological Mesh RS
    K143426 Wound Matrix TF
    K140510 MIROMATRIX WOUND MATRIX
    K134033 MIROMATRIX BIOLOGICAL MESH