BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    ORiGO System

    K Number: K213697 · Decision Oct 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    25
    Applicant Total
    5
    Review Days
    342

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    Basic Information

    Device Name
    ORiGO System
    K Number
    K213697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4360
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bien-Air Surgery SA
    Date Received
    November 23, 2021
    Decision Date
    October 31, 2022
    Product Code
    HBC
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBC Motor, Drill, Electric

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    Other Clearances by Bien-Air Surgery SA

    K Number Device Name
    K221184 ORiGO System
    K173066 OSSEODUO Shaver and Drill System
    K143492 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
    K083720 OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K