What level of detail is required when describing the predicate device in a 510(k) submission?

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. Jul 21, 2016 ... The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least ... Premarket Notification vs Premarket Approval. Phillips stressed that the premarket notification, or 510(k), process is a classification process, whereas PMA is ... Mar 7, 2022 ... Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug ... • Devices approved by the FDA through the Pre-Market Approval (PMA) process;. • Devices cleared by the FDA through the 510(k) process;. • FDA-approved ... To receive FDA approval on a new device intended for human use, a premarket submission called a 510k must be made to the FDA. This must demonstrate that the ... 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 ... Mar 18, 2024 ... What do the different FDA terms mean? Regulatory professionals ... All other Class II devices require 510(K) clearance as a premarket ... Jan 17, 2023 ... Henry further said it's important to keep in mind that the definition of “recall” is broad and doesn't necessarily mean a product was so ... Jan 7, 2025 ... This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can ...