POLYGON MEDICAL, INC.

Polygon Medical, Inc. specializes in tissue morcellation systems, which are used during surgical procedures to fragment tissue into smaller pieces. Their primary focus is on devices like the Polygon and Polygon Resection Device, designed for applications where controlled tissue breakdown is required.

Polygon Medical, Inc. is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight, as its devices are subject to U.S. medical device regulations.

Polygon Medical, Inc.’s devices are included in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have undergone the required FDA review process for Class II categorization.

Polygon Medical, Inc.’s tissue morcellation systems, such as the Polygon and Polygon Resection Device, fall under Class II classification by the FDA. This classification indicates moderate regulatory controls, including performance standards or special controls, to ensure their safety and effectiveness for intended surgical use.