FDA 510(k)

Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)

Numéro K : K262488 · 2026-09-09

DemandeurGuangzhou Red Pine Medical Instrument Co., Ltd.

Date de décision2026-09-09

Code produitFGB

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) 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 2026-09-09 under 510(k) number K262488. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)?

Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) is a medical device that received FDA 510(k) clearance on 2026-09-09. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K262488.

When did Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) receive FDA 510(k) clearance?

Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) received FDA 510(k) clearance on 2026-09-09, under 510(k) number K262488.

Who is the listed applicant for Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)?

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 Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)?

The FDA product code for Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) is FGB.

Essais cliniques associés

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

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)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 : FGB)

K261447CVAC® Aspiration SystemCalyxo, Inc.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.K252929Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)Anhui Happiness Workshop Instruments Co., Ltd.

Source officielle

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