BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    ADHEAR System

    K Number: K172460 · Decision Apr 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    50
    Applicant Total
    6
    Review Days
    256

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ADHEAR System
    K Number
    K172460
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3302
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Med-El Elektromedizinische Geraete GmbH
    Date Received
    August 14, 2017
    Decision Date
    April 27, 2018
    Product Code
    LXB
    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
    LXB Hearing Aid, Bone Conduction

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LXB), ordered by most recent decision date.

    Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    contact forte Alpha

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Ponto 5 SuperPower

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Med-El Elektromedizinische Geraete GmbH

    K Number Device Name
    K201983 BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)
    K200504 BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
    K191457 BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
    K183373 Bonebridge
    DEN170009 Bonebridge