# Suzhou Shenyun Medical Equipment Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: GCJ (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
- Covidien: 1 (https://510kreport.com/company/covidien)
- Louisville Laboratories, Inc.: 1 (https://510kreport.com/company/louisville-laboratories)

## Recent decisions
- K260197: Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (Apr 8, 2026)

Source page: https://510kreport.com/company/suzhou-shenyun-medical-equipment