Pare Surgical, Inc.

Pare Surgical, Inc. specializes in single-use medical devices primarily for surgical applications. Their most common products are monopolar electrosurgical handpieces and electrodes designed for open-surgery procedures. Additionally, they produce the PARE Endoscopic Suturing System, which is tailored for minimally invasive surgeries requiring precise tissue suturing. These devices leverage electrosurgical technology to assist surgeons in cutting and sealing tissue during procedures.

Pare Surgical, Inc. is headquartered in the United States. Since the company operates within the US, its devices are subject to FDA regulations. The FDA classifies their products as Class II, indicating a moderate level of risk that requires special controls to ensure safety and effectiveness. This classification is determined based on the device’s intended use and potential health impact, as outlined in FDA guidelines.

Pare Surgical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures accurate identification, tracking, and traceability of medical devices throughout their lifecycle. These listings help healthcare providers, regulators, and manufacturers verify compliance and access critical information about the devices.

Pare Surgical, Inc.’s devices are classified as Class II under US regulations. This classification means they pose a moderate risk and require additional controls beyond general controls to ensure their safety and effectiveness. For users, this classification implies that the devices undergo rigorous review by the FDA, including performance testing and labeling requirements, to mitigate risks while maintaining their intended surgical benefits.

Yes, Pare Surgical, Inc. produces devices for both open-surgery and minimally invasive procedures. Their monopolar electrosurgical handpieces and electrodes are designed for open-surgery applications, while the PARE Endoscopic Suturing System is specifically engineered for minimally invasive surgeries. This dual focus allows the company to cater to a range of surgical needs, from traditional open procedures to advanced endoscopic techniques.