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

    Dynarex Eye Cups

    K Number: K151575 · Decision Sep 1, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    82

    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
    Dynarex Eye Cups
    K Number
    K151575
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dynarex Corporation
    Date Received
    June 11, 2015
    Decision Date
    September 1, 2015
    Product Code
    LXQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXQ Cup, Eye

    Similar 510(k) Clearances

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

    FLENTS PLASTIC EYE WASH CUP

    FDA 510(k)
    FDA Unclassified ·Unknown

    EYE CUP, STERILE 1 AND NON STERILE

    FDA 510(k)
    FDA Unclassified ·Unknown

    VISTA EYESHOWER

    FDA 510(k)
    FDA Unclassified ·Unknown

    ADVANCE DIAGNOSTICS DISPOSABLE EYECUP

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Dynarex Corporation

    K Number Device Name
    K172266 Dynarex Three-Way Stopcock
    K152970 Dynarex Xeroform Petrolatum Dressing
    K103086 DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC
    K102637 DYNAREX ULTRASOUND GEL
    K092488 DYNAREX STERILE LUBRICATING JELLY
    K082863 DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
    K081569 DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS