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FDA 510(k)

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)

N.º K: K220159 · 2022-08-26

SolicitanteShanghai AnQing Medical Instrument Co., Ltd.
Fecha de decisión2022-08-26
Código de productoFGB
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) 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 2022-08-26 under 510(k) number K220159. 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 Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)?

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) is a medical device that received FDA 510(k) clearance on 2022-08-26. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K220159.

When did Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) receive FDA 510(k) clearance?

Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) received FDA 510(k) clearance on 2022-08-26, under 510(k) number K220159.

Who is the listed applicant for Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)?

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 Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US)?

The FDA product code for Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) is FGB.

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

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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-28USK243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

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Dispositivos relacionados (Código: FGB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 CorporationK262552Single-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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