FDA 510(k)

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)

N.º K: K243857 · 2025-04-11

SolicitanteShanghai AnQing Medical Instrument Co., Ltd.

Fecha de decisión2025-04-11

Código de productoFGB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Flexible Ureterorenoscope (US27F-12-EU; US27F-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 2025-04-11 under 510(k) number K243857. 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 (US27F-12-EU; US27F-12-US)?

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K243857.

When did Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) receive FDA 510(k) clearance?

Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243857.

Who is the listed applicant for Flexible Ureterorenoscope (US27F-12-EU; US27F-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 (US27F-12-EU; US27F-12-US)?

The FDA product code for Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) 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 K231105Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)

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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