Human Xtensions , Ltd.

Human Xtensions, Ltd. specializes in two primary categories of medical devices: endoscopic electromechanical surgical systems and single-use monopolar electrosurgical electrodes. Their product line includes reusable instruments like the HandX system and disposable electrodes such as monopolar hooks, spatulas, scissors, needle holders, and fenestrated graspers. These devices are designed for minimally invasive surgical procedures, particularly in laparoscopic and endoscopic applications.

Human Xtensions, Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their products as Class II, which typically requires premarket notification (510(k)) clearance before commercial distribution. This classification reflects a moderate level of risk associated with the devices, necessitating regulatory oversight to ensure safety and effectiveness.

Human Xtensions, Ltd.'s devices are listed in the FDA’s 510(k) database, which tracks premarket notifications for Class II devices, and the FDA’s Unique Device Identifier (UDI) database. The 510(k) listing confirms that each device has undergone the required regulatory review process, while the UDI database ensures standardized identification and traceability of the devices in the market.

Human Xtensions, Ltd.'s devices are classified as Class II under FDA regulations. This classification indicates that while the devices are not considered high-risk (like Class III), they still pose some risk and require specific controls to ensure their safety and performance. Class II devices typically require a 510(k) premarket submission to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory standards before entering the market.

Human Xtensions, Ltd.'s devices are primarily designed for minimally invasive surgical procedures, including laparoscopic and endoscopic surgeries. Their endoscopic electromechanical systems and monopolar electrosurgical electrodes are tailored for precision tasks such as tissue dissection, coagulation, and manipulation. These instruments are commonly used in general surgery, gynecology, urology, and other specialties where minimally invasive techniques are preferred.