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

    STORZ MICRO CUTTER 25 GAUGE PACK

    K Number: K913504 · Decision Feb 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    6
    Review Days
    198

    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
    STORZ MICRO CUTTER 25 GAUGE PACK
    K Number
    K913504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Storz
    Date Received
    August 7, 1991
    Decision Date
    February 21, 1992
    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 Storz

    K Number Device Name
    K960007 STORZ MVS 1011A DISPOSABLE FIBEROPTIC ENDOILLUMINATOR
    K952151 STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)
    K954340 STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
    K930278 STORZ COMPUSCAN AB
    K926512 STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE