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

    Restrata®

    K Number: K193583 · Decision Sep 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    18
    Applicant Total
    7
    Review Days
    277

    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
    Restrata®
    K Number
    K193583
    Device Class
    FDA unclassified
    Clearance Type
    Special
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acera Surgical, Inc.
    Date Received
    December 23, 2019
    Decision Date
    September 25, 2020
    Product Code
    QSZ
    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
    QSZ Absorbable Synthetic Wound Dressing

    Similar 510(k) Clearances

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

    Redermo Wound Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    NovoSorb BTM

    FDA 510(k)
    FDA Unclassified ·Unknown

    NovoSorb® MTX

    FDA 510(k)
    FDA Unclassified ·Unknown

    SiOxD® Wound Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    SiOxD Wound Matrix

    FDA 510(k)
    FDA Unclassified ·Unknown

    Restrata® MiniMatrix

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Acera Surgical, Inc.

    K Number Device Name
    K251224 Restrata Soft Tissue Reinforcement (STR)
    K223725 Restrata® MiniMatrix
    K172603 Cerafix Dura Substitute
    K170300 Restrata Wound Matrix
    K161278 Cerafix Dura Substitute
    K153613 Cerafix Dura Substitute