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FDA 510(k)

Single-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)

K-Number: K251951 · 2025-12-16

ApplicantGuangzhou Red Pine Medical Instrument Co., Ltd.
Decision Date2025-12-16
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-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) 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 2025-12-16 under 510(k) number K251951. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-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)?

Single-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) is a medical device that received FDA 510(k) clearance on 2025-12-16. The listed applicant is Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K251951.

When did Single-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) receive FDA 510(k) clearance?

Single-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) received FDA 510(k) clearance on 2025-12-16, under 510(k) number K251951.

Who is the listed applicant for Single-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)?

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-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)?

The FDA product code for Single-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) is FGB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07353255Fibrescope vs Videolaryngoscope for Nasotracheal IntubationRECRUITINGNCT06596655Single Use Bronchoscopes for Interventional PulmonologyRECRUITINGNCT07557589Radiofrequency Treatment for Pilonidal Disease : Clinical Investigation on Safety of Use, Efficacy and Patient Satisfaction at 6 MonthsRECRUITING

Other records listing Guangzhou Red Pine Medical Instrument Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B)

View all 9 devices →

Related Devices (Code: FGB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K260013CVAC Image ProcessorCalyxo, Inc.K252468Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)Zhejiang Geyi Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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