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

    GELENDER VACUUM FIXATION RING SYS

    K Number: K832912 · Decision Jan 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    134

    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
    GELENDER VACUUM FIXATION RING SYS
    K Number
    K832912
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Miami Eye Technology, Inc.
    Date Received
    August 29, 1983
    Decision Date
    January 10, 1984
    Product Code
    HNH
    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
    HNH Ring, Ophthalmic (Flieringa)

    Similar 510(k) Clearances

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

    LANDERS NOTCHED VITRECTOMY LENS RING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LANDERS THREE STRUT VITRECTOMY LENS RING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LANDERS VITRECTOMY LENS RING W/INFUSION

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RK VACUUM FIXATION RING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    LANDERS VITRECTOMY LENS RING SYSTEMS

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

    Other Clearances by Miami Eye Technology, Inc.

    K Number Device Name
    K841101 CLAYMAN-PAREL CAPSULE COUPEUR
    K832996 SURGICAL IOP MONITOR
    K832997 EPA AUTOMATED INFUSION POLE
    K832911 ABBOTT GLOBE HOLDER
    K831702 RARE-EARTH INTRA-OCULAR MAGNET