What are the considerations for obtaining 510(k) clearance for combination products (drug-device or biologic-device)?

Aug 4, 2022 ... “When Xoran states that TRON is the 'One RING to rule them all,' we truly mean that this compact, mobile, open-bore device is poised to ... Feb 4, 2025 ... FDA clearance through the 510(k) process means the agency agrees ... What does it mean to be 510(k) exempt? Some medical devices are ... May 6, 2021 ... What is the risk of recall and high-risk recall for devices undergoing US Food and Drug Administration (FDA) 510(k) clearance compared with ... Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. ... The phrase “substantially equivalent” means your ... Apr 2, 2024 ... "Olympus is your trusted stone management partner and now is positioned to provide access to a broad range of high-quality ureteroscopes, ... May 29, 2024 ... This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a ... Jul 3, 2024 ... What exactly does this mean? I have heard this tossed around for some time and want to learn more about the specifics of a FDA 510(k) ... Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Oct 4, 2023 ... Anumana's ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk for heart failure. The goal of a FDA 510k submission is to demonstrate that the device being brought to market is at least as safe and effective to another legally marketed ...