Bipad, Inc.

Bipad, Inc. specializes in single-use bipolar electrosurgical handpieces and electrodes. Their products are primarily designed for open-surgery applications, including disposable bipolar electrocautery cords, Y-connectors, and unpackaged 4-prong connectors. These devices are intended for use with electrosurgical generators to facilitate precise tissue management during surgical procedures.

Bipad, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

Bipad, Inc.’s devices 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 performance standards, labeling requirements, or post-market surveillance.

Yes, Bipad, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory compliance and post-market monitoring.

Bipad, Inc.’s products are designed exclusively for open-surgery procedures, where bipolar electrosurgery is used to cut and coagulate tissue. The single-use nature of their handpieces and electrodes helps reduce infection risks and ensures sterile conditions in surgical environments.