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

    Ureterorenoscope System

    K Number: K201293 · Decision Jul 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    14
    Review Days
    71

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    Basic Information

    Device Name
    Ureterorenoscope System
    K Number
    K201293
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai AnQing Medical Instrument Co., Ltd.
    Date Received
    May 14, 2020
    Decision Date
    July 24, 2020
    Product Code
    FGB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FGB Ureteroscope And Accessories, Flexible/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. →