BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GALLIE CRYONUCLEATOR

    K Number: K833747 · Decision May 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    196

    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
    GALLIE CRYONUCLEATOR
    K Number
    K833747
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Mono Research Laboratories
    Date Received
    October 26, 1983
    Decision Date
    May 9, 1984
    Product Code
    HPS
    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
    HPS Unit, Cryophthalmic

    Similar 510(k) Clearances

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

    CryoTreQ

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OPHTHALMIC CRYO UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    OPHTHALMIC TRICHIASIS PROBE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KEELER ACU 22XT OPHTHALMIC CRYO UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KEELER CTU CRYO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all