Moon Surgical, Inc.

Moon Surgical, Inc. specializes in surgical camera holders, primarily for laparoscopic procedures. Their portfolio includes the Maestro System, which stabilizes and positions endoscopes or cameras during minimally invasive surgeries, ensuring optimal visualization for surgical teams. They also produce Maestro Couplers in 5mm and 10mm sizes, as well as non-sterile couplers designed to connect modular instruments to the Maestro Platform. These devices are engineered to enhance surgical workflows in minimally invasive procedures.

Moon Surgical, Inc. is headquartered in the United States. Their devices are listed in key regulatory databases, including the EU’s EUDAMED system for European market compliance, as well as the FDA’s 510(k) and UDI registries for the U.S. market. This reflects their focus on adhering to regulatory requirements in both jurisdictions, though individual device authorizations depend on the specific product and regional approval pathways.

Moon Surgical’s devices fall under Class I and Class II classifications, depending on the product. Class I devices typically pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory scrutiny and documentation requirements for each device, such as pre-market notifications (e.g., FDA 510(k)) or conformity assessments (e.g., EU MDR).

Moon Surgical’s devices are listed in several regulatory registries to demonstrate compliance and traceability. These include the EUDAMED database (for EU market access), the FDA’s 510(k) premarket notification registry (for U.S. clearance), and the FDA’s Unique Device Identifier (UDI) system, which standardizes device identification for tracking and post-market surveillance. Listing in these systems helps healthcare providers and regulators verify the device’s authorized status and compliance history.