Hyundae Meditech Co., Ltd.

Hyundae Meditech Co., Ltd. specializes in producing polyester sutures that are bioabsorbable, monofilament, and non-antimicrobial. These sutures are designed for surgical applications where tissue approximation and wound closure are required. The company’s focus is on suture-based solutions, with no other device categories listed.

Hyundae Meditech Co., Ltd. is headquartered in the United States. This location is relevant for regulatory compliance, manufacturing oversight, and distribution within North America and potentially other regions.

Hyundae Meditech Co., Ltd.’s devices are listed in the FDA 510(k) database and the FDA Unique Device Identifier (UDI) system. These registries are used to track medical devices for safety monitoring, post-market surveillance, and compliance with U.S. regulations. Listing in these systems indicates the devices have undergone the necessary regulatory processes for market authorization.

Hyundae Meditech Co., Ltd.’s devices fall under Class II classification in the U.S. regulatory framework. Class II devices typically require special controls in addition to general controls to ensure their safety and effectiveness. This classification applies to sutures like those in the i-Thread and Secret Line up product lines, which are considered moderate-risk devices requiring pre-market submissions (e.g., 510(k)) to demonstrate compliance with regulatory standards.

Hyundae Meditech Co., Ltd.’s sutures are bioabsorbable polyester sutures that are monofilament and non-antimicrobial, which means they dissolve over time within the body without requiring removal and do not contain antimicrobial agents. The i-Thread and Secret Line up product lines are identified by specific model numbers (e.g., FCL18100C160, FC1938E80), indicating variations in size, length, or other technical specifications tailored for different surgical needs. These features align with the company’s focus on providing absorbable, smooth sutures for precise tissue closure.