Single-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)— 510(k) K252468

Substantially Equivalent

Zhejiang Geyi Medical Instrument Co., Ltd.

FDA 510(k) clearance K252468 for Single-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), Substantially Equivalent on 2025-12-16. Applicant: Zhejiang Geyi Medical Instrument Co., Ltd..

Clearance details

Applicant: Zhejiang Geyi Medical Instrument Co., Ltd.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-06
Decision date: 2025-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiande City, CN

Download summary PDF View on FDA.gov ↗

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, 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.