# Zhejiang Geyi Medical Instrument Co., Ltd.

- Location (FDA's records): Jiande City, CN
- FDA decisions: 2 (2025–2026): 2 510(k) clearances
- Product codes: FGB (1), HIH (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zhuhai Pusen Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhuhai-pusen-medical-technology)
- MacroLux Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/macrolux-medical-technology)

## Recent decisions
- K254294: Single-use Digital Hysteroscope (GYUT-A 12.6- 0,  GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30,  GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22,  GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12,  GYUT-B 15-22, GYUT-B 15- 30) (Sep 8, 2026)
- K252468: 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) (Dec 16, 2025)

Source page: https://510kreport.com/company/zhejiang-geyi-medical-instrument
