# Seplou (Zhuhai) Co., Ltd.

- Location (FDA's records): Zhuhai, CN
- FDA decisions: 2 (2025–2025): 2 510(k) clearances
- Product codes: FGB (1), FED (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)
- Well Lead Medical Co., Ltd.: 1 (https://510kreport.com/company/well-lead-medical)

## Recent decisions
- K250049: Medical Video Endoscope [Standard Deflection]  (URS3005); Medical Video Endoscope [Reverse Deflection]  (URS3005E); Medical Video Endoscope [Standard Deflection]  (URS3006); Medical Video Endoscope [Reverse Deflection]  (URS3006E); Medical Video Endoscope [Standard Deflection]  (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) (Aug 26, 2025)
- K243025: Ureteral Access Sheath (Jan 30, 2025)

Source page: https://510kreport.com/company/seplou-zhuhai