Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)— 510(k) K241500

Substantially Equivalent

Guangzhou Red Pine Medical Instrument Co., Ltd.

FDA 510(k) clearance K241500 for Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS), Substantially Equivalent on 2024-07-12. Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd..

Clearance details

Applicant: Guangzhou Red Pine Medical Instrument Co., Ltd.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-28
Decision date: 2024-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.