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

    OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)

    K Number: K940508 · Decision May 4, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    21
    Same Product Code
    30
    Applicant Total
    8
    Review Days
    89

    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
    OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
    K Number
    K940508
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    G.W.B. Intl., Ltd.
    Date Received
    February 4, 1994
    Decision Date
    May 4, 1994
    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 G.W.B. Intl., Ltd.

    K Number Device Name
    K955671 RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
    K954094 OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)
    K950569 OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}
    K911110 OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
    K911108 OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
    K911109 OPHTA SIL (R), LACHRYMAL INTUBATION SETS
    K896029 DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20