BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

    K Number: K240614 · Decision Jul 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    10
    Applicant Total
    16
    Review Days
    127

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    Basic Information

    Device Name
    Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS
    K Number
    K240614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3340
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oticon Medical AB
    Date Received
    March 5, 2024
    Decision Date
    July 10, 2024
    Product Code
    PFO
    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
    PFO Active Implantable Bone Conduction Hearing System

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    Other Clearances by Oticon Medical AB

    K Number Device Name
    K213733 Ponto 5 SuperPower
    K211640 Ponto 5 Mini
    K203807 Ponto Bone Anchored Hearing System, MONO Surgery Kit
    K190540 Ponto 4
    K161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
    K152820 Ponto Bone Anchored Hearing System
    K152067 Ponto bone anchored hearing system
    K142678 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
    K141616 STERILIZATION CASSETTE
    K132775 PONTO PLUS AND PONTO PLUS POWER
    Search all 16 clearances from Oticon Medical AB →