Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)— 510(k) K262488
Substantially EquivalentGuangzhou Red Pine Medical Instrument Co., Ltd.
FDA 510(k) clearance K262488 for Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3), Substantially Equivalent on 2026-09-09. Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.. Device class: 2.
Summary
Single-Use Video Flexible Ureterorenoscope is from Guangzhou Red Pine Medical Instrument Co., Ltd., filed under product code FGB (Ureteroscope And Accessories, Flexible/Rigid). The name lists four models: RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, and RP-U-C06S3. The record doesn't say how they differ.
Class II, 21 CFR 876.1500. Gastroenterology, Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Red Pine filed from Guangzhou, China. The decision came 51 calendar days after FDA received it (July 20 to September 9, 2026).
Clearance details
- Applicant
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Product code
- Product code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code FGB
view all- K262437 — Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
- K260708 — Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection) +1 more
- K261447 — CVAC® Aspiration System
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)
More clearances from Guangzhou Red Pine Medical Instrument Co., Ltd.
view all- K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3) +2 more
- K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
- K243321 — Endoscopic Video Image Processor (RP-IPD-V1000F)
- K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
- K241500 — Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.