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

    AC5 Topical Gel

    K Number: K182681 · Decision Dec 14, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    2
    Review Days
    79

    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
    AC5 Topical Gel
    K Number
    K182681
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Arch Therapeutics, Inc.
    Date Received
    September 26, 2018
    Decision Date
    December 14, 2018
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

    Similar 510(k) Clearances

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

    Bonvadis®

    FDA 510(k)
    FDA Unclassified ·Unknown

    StatSeal Disc

    FDA 510(k)
    FDA Unclassified ·Unknown

    IWD-Gel™

    FDA 510(k)
    FDA Unclassified ·Unknown

    MiraChlor Antimicrobial Wound Solution

    FDA 510(k)
    FDA Unclassified ·Unknown

    Promogran Prisma™ Collagen Matrix with ORC and Silver

    FDA 510(k)
    FDA Unclassified ·Unknown

    LUOFUCON® Antimicrobial Wound Gel

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Arch Therapeutics, Inc.

    K Number Device Name
    K190129 AC5 Topical Gel