Suture Concepts Inc.

Suture Concepts Inc. specializes in two primary categories of medical devices: sterile multi-purpose surgical adhesive tape, which is used for wound closure and securing medical devices during surgery, and neural-tissue electrical stimulation lead adaptors. These adaptors, such as the Lead Loop, are designed to facilitate connections in neurostimulation systems, ensuring proper functionality in neural-tissue applications.

Suture Concepts Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these devices as either Class I or Class II, depending on their risk level and intended use, ensuring compliance with U.S. medical device standards.

Yes, Suture Concepts Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing is important because it provides transparent, standardized identification of medical devices, helping healthcare providers, regulators, and manufacturers track and manage devices throughout their lifecycle. It also supports traceability and compliance with FDA requirements.

Suture Concepts Inc.’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls for regulation, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device type.