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

    OPTHALMIC SURGICAL INSTRUMENTS

    K Number: K860744 · Decision Mar 31, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    7
    Review Days
    32

    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
    OPTHALMIC SURGICAL INSTRUMENTS
    K Number
    K860744
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Tridak Division of Indicon, Inc.
    Date Received
    February 27, 1986
    Decision Date
    March 31, 1986
    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 Tridak Division of Indicon, Inc.

    K Number Device Name
    K891007 NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
    K853059 LABORIE FIBEROPTIC PRESSURE SENSOR & INTERFACE
    K852856 LABORIE URODYNAMICS PROCESSOR
    K851934 CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA
    K842609 R.L. MEDICAL TWIN LIGHT SOURCE
    K840605 LABORIE FIBREOPTIC LIGHT CABLE