# Lagis Enterprise Co., Ltd.

- Location (FDA's records): Taichung City, TW
- FDA decisions: 3 (2024–2026): 3 510(k) clearances
- Product codes: GCJ (2), GEI (1)
- 510(k) review time since 2016: median 237 days, against 108 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (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
- Alliance Medical Corp.: 1 (https://510kreport.com/company/alliance-medical)
- Taiwan Surgical Corporation: 1 (https://510kreport.com/company/taiwan-surgical)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)

## Recent decisions
- K253134: LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) (May 20, 2026)
- K243867: LAGIS Suction Irrigation System (Mar 17, 2025)
- K240334: LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D,  DI-5731-33D, DI-5731-45D,  DI-5901-33D, DI-5901-45D) (Oct 30, 2024)

Source page: https://510kreport.com/company/lagis-enterprise