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

    ORiGO System

    K Number: K221184 · Decision Nov 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    90
    Applicant Total
    4
    Review Days
    191

    Basic Information

    Device Name
    ORiGO System
    K Number
    K221184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4250
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bien-Air Surgery SA
    Date Received
    April 25, 2022
    Decision Date
    November 2, 2022
    Product Code
    ERL
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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    Other Clearances by Bien-Air Surgery SA

    K Number Device Name
    K213697 ORiGO System
    K173066 OSSEODUO Shaver and Drill System
    K143492 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece