Class Class II

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K252176)

K252176 2025-08-08 Special
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Description

Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) by Guangzhou Red Pine Medical Instrument Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK252176
Clearance Date2025-08-08
Clearance TypeSpecial
Product CodeFAJ
Regulation Number876.1500

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Predicate lineage for K252176

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K252176) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-U...Guangzhou Red Pine Medical Instrume...2024

Trace the full predicate network for K252176

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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