FDA 510(k)

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)

K-Number: K252176 · 2025-08-08

ApplicantGuangzhou Red Pine Medical Instrument Co., Ltd.

Decision Date2025-08-08

Product CodeFAJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is a medical device manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-08-08 under approval number K252176. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd.. The 510(k) number is K252176.

When was Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) approved by the FDA?

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) received FDA 510(k) clearance on 2025-08-08, under approval number K252176.

What company makes Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is manufactured by Guangzhou Red Pine Medical Instrument Co., Ltd..

What is the FDA product code for Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)?

The FDA product code for Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) is FAJ.

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Other Devices by Guangzhou Red Pine Medical Instrument Co., Ltd.

K221158Single-Use Video Flexible Ureterorenoscope System 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) K232003Endoscopic Video Image Processor, Single-Use Video Hysteroscope

View all 9 devices →

Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

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.