BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EYE IRRIGATOR MODEL #2020

    K Number: K980647 · Decision May 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    87

    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
    EYE IRRIGATOR MODEL #2020
    K Number
    K980647
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eye-Deal Ocular Safety Products, Inc.
    Date Received
    February 17, 1998
    Decision Date
    May 15, 1998
    Product Code
    KYG
    Advisory Committee
    Ophthalmic
    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
    KYG Device, Irrigation, Ocular Surgery

    Similar 510(k) Clearances

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

    MED-LOGICS DISPOSABLE ALK TUBING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BLADEWORKS DISPOSABLE ALK TUBING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SOVEREIGN CATARACT EXTRACTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MOISTAIR FLUID AIR TUBING SET

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ML DISPOSABLE ALK TUBING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all