Medical Device Manufacturer · TW , Taichung City

Lagis Enterprise Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2024

Recent clearances: LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T), LAGIS Suction Irrigation System, 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)

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Lagis Enterprise Co., Ltd. General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared May 20, 2026

LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)

General & Plastic Surgery · 237d

Cleared Mar 17, 2025

LAGIS Suction Irrigation System

General & Plastic Surgery · 90d

Cleared Oct 30, 2024

LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D,...

General & Plastic Surgery · 268d