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

    EV MONOCANALICULAR STENT (TM)

    K Number: K883233 · Decision Aug 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    21
    Same Product Code
    30
    Applicant Total
    7
    Review Days
    21

    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
    EV MONOCANALICULAR STENT (TM)
    K Number
    K883233
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Eagle Vision, Inc.
    Date Received
    August 1, 1988
    Decision Date
    August 22, 1988
    Product Code
    OKS
    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
    OKS Lacrimal Stents And Intubation Sets

    Similar 510(k) Clearances

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

    Ritleng®+ and Ritleng®+ PVP

    FDA 510(k)
    FDA Unclassified ·Unknown

    LacriJet®

    FDA 510(k)
    FDA Unclassified ·Unknown

    Lacriflow CL

    FDA 510(k)
    FDA Unclassified ·Unknown

    Nunchaku

    FDA 510(k)
    FDA Unclassified ·Unknown

    Oasis Lacrimal Intubation Set

    FDA 510(k)
    FDA Unclassified ·Unknown

    DacryoCATH

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Eagle Vision, Inc.

    K Number Device Name
    K053333 EAGLEVISION GELLANSERTS, MODEL REF 0040
    K030353 MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
    K991130 FLEXPLUG
    K905427 EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
    K890919 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
    K890920 EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE