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

    BD K-4000 MICROKERATOME SYSTEM

    K Number: K023092 · Decision Oct 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    11
    Applicant Total
    190
    Review Days
    30

    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
    BD K-4000 MICROKERATOME SYSTEM
    K Number
    K023092
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    886.4370
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson & CO
    Date Received
    September 18, 2002
    Decision Date
    October 18, 2002
    Product Code
    HMY
    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
    HMY Keratome, Battery-Powered

    Similar 510(k) Clearances

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

    ONEUSE- PLUS MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    M2 SINGLE USE MICROKERTOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CARRIAZO BARRAQUER SINGLE USE MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CARRIAZO BARRAQUER II MICROKERATOME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MILLENIUM MICROKERATOME, MODEL IMD-001

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

    Other Clearances by Becton, Dickinson & CO

    K Number Device Name
    K160164 BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
    K160161 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
    K141474 BECTON DICKINSON INTELLIPORT SYSTEM
    K140446 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
    K140448 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
    K140591 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR
    K133140 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV
    K133138 BD Veritor™ System Flu A+B Assay
    K130268 BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
    K131301 BD FACS SAMPLE PREP ASSISTANT III
    Search all 190 clearances from Becton, Dickinson & CO →