BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Bronchoscope System

    K Number: K211169 · Decision Nov 24, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    14
    Review Days
    219

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    Basic Information

    Device Name
    Bronchoscope System
    K Number
    K211169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai AnQing Medical Instrument Co., Ltd.
    Date Received
    April 19, 2021
    Decision Date
    November 24, 2021
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by Shanghai AnQing Medical Instrument Co., Ltd.

    K Number Device Name
    K254251 InnovexView (GC146-17, GC150-20, GC155-23)
    K252806 Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
    K252598 Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
    K251752 Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
    K243497 Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US
    K243857 Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
    K231105 Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
    K222162 Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
    K222737 Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
    K220159 Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)
    Search all 14 clearances from Shanghai AnQing Medical Instrument Co., Ltd. →