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

    Hydrocleanse Antimicrobial Skin and Wound Care Solution

    K Number: K171727 · Decision Jul 26, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    2
    Review Days
    44

    Basic Information

    Device Name
    Hydrocleanse Antimicrobial Skin and Wound Care Solution
    K Number
    K171727
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonoma Pharmaceuticals
    Date Received
    June 12, 2017
    Decision Date
    July 26, 2017
    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

    Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel

    FDA 510(k)
    FDA Unclassified ·Unknown

    Spectricept Skin and Wound Cleanser

    FDA 510(k)
    FDA Unclassified ·Unknown

    SiOxC Cream

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sterile Water USP and Sterile 0.9% Normal Saline USP

    FDA 510(k)
    FDA Unclassified ·Unknown

    LUOFUCON® Silver Collagen Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Sonoma Pharmaceuticals

    K Number Device Name
    K172622 Microcyn Antimicrobial Skin and Wound Cleanser