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

    OCU-1

    K Number: K875030 · Decision May 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    6
    Review Days
    148

    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
    OCU-1
    K Number
    K875030
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Rudolph Beaver, Inc.
    Date Received
    December 7, 1987
    Decision Date
    May 3, 1988
    Product Code
    HMX
    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
    HMX Cannula, Ophthalmic

    Similar 510(k) Clearances

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

    WEISS RETINAL CANNULA

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    STERISEAL OPHTHALMIC CANNULA

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    INFUSION CANNULA

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    INTER TIP T

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

    Other Clearances by Rudolph Beaver, Inc.

    K Number Device Name
    K883361 ARTHRO-TRAC(TM)
    K862709 MECHANICAL CYSTITOME
    K860305 BEAVER MICRO-GEM GAUGE BLOCK
    K852828 BEAVER R-K KNIFE
    K853129 BEAVER MULTIPURPOSE SAPPHIRE KNIFE