FDA 510(k)

Ureterorenoscope System

N.º K: K180367 · 2018-07-03

SolicitanteShanghai AnQing Medical Instrument Co., Ltd.

Fecha de decisión2018-07-03

Código de productoFGB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ureterorenoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2018-07-03 under 510(k) number K180367. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ureterorenoscope System?

Ureterorenoscope System is a medical device that received FDA 510(k) clearance on 2018-07-03. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K180367.

When did Ureterorenoscope System receive FDA 510(k) clearance?

Ureterorenoscope System received FDA 510(k) clearance on 2018-07-03, under 510(k) number K180367.

Who is the listed applicant for Ureterorenoscope System?

The FDA 510(k) record lists Shanghai AnQing Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureterorenoscope System?

The FDA product code for Ureterorenoscope System is FGB.

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Otros registros que enlistan a Shanghai AnQing Medical Instrument Co., Ltd. como solicitante

K254251InnovexView (GC146-17, GC150-20, GC155-23)K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)K243497Portable 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 K243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

Ver todos los 14 dispositivos →

Dispositivos relacionados (Código: FGB)

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

Fuente oficial

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