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

    AARON VAC 2

    K Number: K952558 · Decision Mar 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    46
    Review Days
    656

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    Basic Information

    Device Name
    AARON VAC 2
    K Number
    K952558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aaron Medical Industries
    Date Received
    June 2, 1995
    Decision Date
    March 19, 1997
    Product Code
    HKP
    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
    HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered

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    K014201 AARON REUSABLE ELECTROSURGICAL ELECTRODE
    K001955 AARON 1250 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1250
    K001382 AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
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    Search all 46 clearances from Aaron Medical Industries →