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

    ARAGON ONESHOT SYSTEM

    K Number: K081312 · Decision Oct 31, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    175

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    Basic Information

    Device Name
    ARAGON ONESHOT SYSTEM
    K Number
    K081312
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aragon Surgical, Inc.
    Date Received
    May 9, 2008
    Decision Date
    October 31, 2008
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Aragon Surgical, Inc.

    K Number Device Name
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    K093075 ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT
    K090306 ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT
    K073452 MODIFICATION TO: ARAGON SURGICAL LAPCAP
    K070651 ARAGON SURGICAL LAPCAP