# Hangzhou Kangji Medical Instrument Co., Ltd.

- Location (FDA's records): Hangzhou, CN
- FDA decisions: 3 (2023–2025): 3 510(k) clearances
- Product codes: GCJ (1), HIF (1), FZP (1)
- 510(k) review time since 2016: median 193 days, against 90 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 8 (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
- Unimax Medical Systems, Inc.: 2 (https://510kreport.com/company/unimax-medical-systems)
- Nelis: 1 (https://510kreport.com/company/nelis)
- Covidien Lp, Formerly Registered AS Tyco Healthcar: 1 (https://510kreport.com/company/covidien-lp-formerly-registered-as-tyco-healthcar)
- Advanced Surgical Concepts: 1 (https://510kreport.com/company/advanced-surgical-concepts)
- Unimicro Medical Systems (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/unimicro-medical-systems-shenzhen)
- Weck Closure Systems: 1 (https://510kreport.com/company/weck-closure-systems)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)

## Recent decisions
- K250643: Disposable Polymer Ligation Clips (Nov 20, 2025)
- K233263: Disposable Trocars (Apr 9, 2024)
- K232401: Disposable Veress Needles (Dec 14, 2023)

Source page: https://510kreport.com/company/hangzhou-kangji-medical-instrument