Lagis Enterprises Co, Ltd.

Lagis Enterprises Co, Ltd. specializes in disposable endoscopic instruments, such as the LAGIS ENDOSCOPIC INSTRUMENTS DISPOSABLE GRASPER. These devices are intended for use in minimally invasive surgical procedures, where precision and single-use reliability are critical.

The company is headquartered in the United States. This location aligns with regulatory frameworks like the FDA, which governs the classification and clearance of its devices.

The company’s devices fall under the FDA’s Class II classification. This designation applies to products that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.

Lagis Enterprises Co, Ltd.’s devices are documented in the FDA’s 510(k) clearance registry. This process demonstrates that each product meets regulatory requirements for safety and equivalence to a legally marketed predicate device before commercial distribution.