FDA 510(k)

Endoscopic Video Image Processor (RP-IPD-V1000F)

Numéro K : K243321 · 2025-02-07

DemandeurGuangzhou Red Pine Medical Instrument Co., Ltd.

Date de décision2025-02-07

Code produitFET

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Endoscopic Video Image Processor (RP-IPD-V1000F) 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 2025-02-07 under 510(k) number K243321. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Endoscopic Video Image Processor (RP-IPD-V1000F)?

Endoscopic Video Image Processor (RP-IPD-V1000F) is a medical device that received FDA 510(k) clearance on 2025-02-07. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K243321.

When did Endoscopic Video Image Processor (RP-IPD-V1000F) receive FDA 510(k) clearance?

Endoscopic Video Image Processor (RP-IPD-V1000F) received FDA 510(k) clearance on 2025-02-07, under 510(k) number K243321.

Who is the listed applicant for Endoscopic Video Image Processor (RP-IPD-V1000F)?

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 Endoscopic Video Image Processor (RP-IPD-V1000F)?

The FDA product code for Endoscopic Video Image Processor (RP-IPD-V1000F) is FET.

Essais cliniques associés

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Autres dossiers indiquant Guangzhou Red Pine Medical Instrument Co., Ltd. en tant que demandeur

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)K241987Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)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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Dispositifs connexes (Code : FET)

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Source officielle

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