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

    KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000

    K Number: K853308 · Decision Oct 4, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    9
    Review Days
    58

    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
    KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
    K Number
    K853308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Frigitronics of Connecticut, Inc.
    Date Received
    August 7, 1985
    Decision Date
    October 4, 1985
    Product Code
    HQE
    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

    Similar 510(k) Clearances

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

    UniVit HE, UniVit UHS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Cetus system, Cetus probe

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bi-Blade Vitrectomy Cutter

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CONSTELLATION VISION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VERSAVIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PROCARE PLUS VITRECTOMY SYSTEM

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

    Other Clearances by Frigitronics of Connecticut, Inc.

    K Number Device Name
    K891282 MIC-100 WITH CRYOPROBES
    K872362 FRIGITRONICS ACC-1000 CAPSULE CUTTER
    K834577 I/A PROBE LINES
    K840536 CRYO SURG 5900
    K834437 KEATES IRRIGATION/ASPIRATION/VITREOUS
    K822599 KEATES I/A SYSTEM FRIGITRONICS 4000
    K811390 CCS100 CRYOSURGICAL SYSTEM
    K760742 CS-76 AND/OR CRYOCARE I