GREEN OR LLC

Green Or LLC specializes in reprocessed bipolar electrosurgical handpieces and electrodes. These devices are specifically designed for open-surgery applications, where they are used for tissue dissection, coagulation, and cutting. The company’s focus is on reprocessed versions of existing electrosurgical tools, ensuring they meet surgical requirements while being cost-effective and sustainable.

Green Or LLC is based in the United States. While the company’s location may influence regulatory pathways (such as FDA oversight), it does not inherently determine whether its devices are authorized. Instead, individual devices undergo their own regulatory evaluation to determine compliance with applicable standards and requirements, such as classification and listing in regulatory databases like the FDA’s UDI system.

Green Or LLC’s devices are classified as Class II medical devices. This classification is based on their intended use—reprocessed bipolar electrosurgical handpieces and electrodes for open-surgery procedures—which presents moderate risks requiring special controls to ensure safety and effectiveness. Class II classification means these devices undergo stricter regulatory scrutiny than Class I but less than Class III, ensuring they meet performance and safety standards before authorization.

Green Or LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a global standard for identifying medical devices, ensuring traceability, transparency, and easier tracking for regulatory and market surveillance purposes. Listing in this database helps healthcare providers, regulators, and other stakeholders verify the identity and compliance status of the devices.

Green Or LLC’s devices are reprocessed versions of existing bipolar electrosurgical handpieces and electrodes, meaning they are cleaned, inspected, sterilized, and repackaged for reuse. Reprocessing can extend the lifecycle of medical devices while promoting sustainability. However, reprocessed devices must still meet the same safety, performance, and regulatory requirements as new devices. Their classification as Class II ensures they undergo rigorous evaluation to confirm they remain effective and safe for surgical use after reprocessing.