FDA 510(k)

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)

Número K: K241987 · 2024-08-02

RequerenteGuangzhou Red Pine Medical Instrument Co., Ltd.

Data da decisão2024-08-02

Código do produtoHIH

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241987. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)?

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K241987.

When did Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) receive FDA 510(k) clearance?

Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241987.

Who is the listed applicant for Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)?

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

What is the FDA product code for Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)?

The FDA product code for Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) is HIH.

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Outros registros que listam Guangzhou Red Pine Medical Instrument Co., Ltd. como candidato(a)

K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)K251951Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)K243321Endoscopic Video Image Processor (RP-IPD-V1000F)K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)K240663Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)

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Fonte oficial

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