FDA 510(k)

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

Número K: K243857 · 2025-04-11

RequerenteShanghai AnQing Medical Instrument Co., Ltd.

Data da decisão2025-04-11

Código do produtoFGB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Shanghai AnQing Medical Instrument Co., Ltd. como candidato(a)

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 os 14 dispositivos →

Dispositivos Relacionados (Código: FGB)

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Fonte oficial

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