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

    KEATES IRRIGATION/ASPIRATION/VITREOUS

    K Number: K834437 · Decision Mar 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    9
    Review Days
    102

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    Basic Information

    Device Name
    KEATES IRRIGATION/ASPIRATION/VITREOUS
    K Number
    K834437
    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
    December 19, 1983
    Decision Date
    March 30, 1984
    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

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    Other Clearances by Frigitronics of Connecticut, Inc.

    K Number Device Name
    K891282 MIC-100 WITH CRYOPROBES
    K872362 FRIGITRONICS ACC-1000 CAPSULE CUTTER
    K853308 KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000
    K834577 I/A PROBE LINES
    K840536 CRYO SURG 5900
    K822599 KEATES I/A SYSTEM FRIGITRONICS 4000
    K811390 CCS100 CRYOSURGICAL SYSTEM
    K760742 CS-76 AND/OR CRYOCARE I