# Zhejiang Soudon Medical Technology Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 5 (2023–2026): 5 510(k) clearances
- Product codes: FBK (1), LQR (1), PKL (1), KNS (1), GCA (1)
- 510(k) review time since 2016: median 87 days, against 177 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 5 (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
- Hangzhou AGS MedTech Co., Ltd.: 5 (https://510kreport.com/company/hangzhou-ags-medtech)

## Recent decisions
- K253013: Disposable Stone Retrieval Balloon Catheter (May 8, 2026)
- K253056: Disposable Stone Extraction Basket (Apr 3, 2026)
- K232450: Disposable Hemostatic Clips (Jan 26, 2024)
- K232442: Disposable Endoscope Injection Needles (Nov 9, 2023)
- K232476: Disposable Sphincterotome (Nov 7, 2023)

Source page: https://510kreport.com/company/zhejiang-soudon-medical-technology