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

    Hysteroscope System

    K Number: K181545 · Decision May 10, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    14
    Review Days
    332

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    Basic Information

    Device Name
    Hysteroscope System
    K Number
    K181545
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai AnQing Medical Instrument Co., Ltd.
    Date Received
    June 12, 2018
    Decision Date
    May 10, 2019
    Product Code
    HIH
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIH Hysteroscope (And Accessories)

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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. →