Class Class II
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) (K252468)
Description
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) by Zhejiang Geyi Medical Instrument Co., Ltd., an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK252468
Clearance Date2025-12-16
Clearance TypeTraditional
Product CodeFGB
Regulation Number876.1500