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

    MICROCYN SKIN AND WOUND HYDROGEL

    K Number: K093585 · Decision Mar 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    7
    Review Days
    109

    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
    MICROCYN SKIN AND WOUND HYDROGEL
    K Number
    K093585
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oculus Innovative Sciences, Inc.
    Date Received
    November 19, 2009
    Decision Date
    March 8, 2010
    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 Oculus Innovative Sciences, Inc.

    K Number Device Name
    K102945 PEDIACYN ATOPIC DERMATITIS HYDROGEL
    K090206 OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
    K090725 OCULUS MICROCYN WOUND GEL
    K060113 DERMACYN WOUND CARE
    K042729 DERMACYN WOUND IRRIGATION
    K041161 MICROCYN WOUND CARE DRESSING