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

    DOMAIN SURGICAL SYSTEM

    K Number: K121881 · Decision Oct 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    114

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    Basic Information

    Device Name
    DOMAIN SURGICAL SYSTEM
    K Number
    K121881
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Domain Surgical, Inc.
    Date Received
    June 26, 2012
    Decision Date
    October 18, 2012
    Product Code
    HGI
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGI Electrocautery, Gynecologic (And Accessories)

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    Other Clearances by Domain Surgical, Inc.

    K Number Device Name
    K142229 Laparoscopic FMsealer
    K141484 OPEN FMSEALER
    K140384 FMWAND HANDPIECE SE
    K130606 FMWAND FERROMAGNETIC SURGICAL SYSTEM
    K110439 DOMAIN SURGICAL SYSTEM