# Suzhou Hengrui Callisyn Biomedical Co., Ltd.

- Location (FDA's records): Suzhou, CN
- FDA decisions: 1 (2018–2018): 1 510(k) clearance
- Product codes: NAJ (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (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
- Biocompatibles UK Limited: 1 (https://510kreport.com/company/biocompatibles-uk)

## Firms that cite its devices most
- Hangzhou Yangshun Medical Technology Co.,Ltd: 1 (https://510kreport.com/company/hangzhou-yangshun-medical-technology)
- Canyon Medical, Inc.: 1 (https://510kreport.com/company/canyon-medical)
- Suzhou Hengrui Hongyuan Medical Co., Ltd.: 1 (https://510kreport.com/company/suzhou-hengrui-hongyuan-medical)

## Its most-cited devices
- K173871: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (2018), cited by 3

## Recent decisions
- K173871: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (Sep 17, 2018)

Source page: https://510kreport.com/company/suzhou-hengrui-callisyn-biomedical