Vortek Surgical, LLC

Vortek Surgical, LLC specializes in single-use, non-sterile patient surgical drapes. These devices are primarily designed to provide procedural coverage and barrier protection during endoscopic and minimally invasive surgeries. The company’s focus is on ensuring sterile field maintenance in surgical environments.

Vortek Surgical, LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory oversight and compliance with U.S. medical device standards.

Vortek Surgical, LLC’s devices are included in the FDA’s 510(k) premarket notification system and the Unique Device Identification (UDI) database. These registries help track and verify the authorization status of medical devices under U.S. regulations.

The company’s devices, such as the ENDODRAPE® product line, fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as surgical drapes used in controlled procedural settings.