What are the key considerations for foreign manufacturers seeking 510(k) clearance for their devices?

Mar 14, 2024 ... The US Food and Drug Administration (FDA) provided 510(k) clearance for da Vinci 5, the company's next-generation multiport robotic system. Dec 22, 2021 ... The FDA clearance is based on data from multiple studies of the ... mean tear film breakup time and meibomian gland secretion score ... FDA has a clear definition of the 510(k) pathway which allows manufacturers ... FDA's Premarket Approval (PMA) pathway. The European Union CE marking ... Mar 17, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, "This FDA 510(k) clearance is a defining moment for Monogram ... Jan 30, 2025 ... In addition to the clearance, AI Optics is ... A total of 196 patients (48.5% women; mean age, 61 years) were identified who had been referred for ... Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! Feb 14, 2025 ... The goal of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a device that has already been cleared by ... Dec 10, 2019 ... The InSet™ Total Shoulder System is used to treat significant disability in degenerative, rheumatoid, and traumatic disease of the glenohumeral ... The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of ... Oct 6, 2020 ... Although FDA's 510(k) program is the most ... clearance, meaning that manufacturers can market their device without clearance from the FDA.