What are the considerations for obtaining 510(k) clearance for urological and gynecological devices?

Deliver more personalised digital-first care and research with our enterprise platform which now has FDA 510 (K) Class II clearance for any physician-specified ... Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... Aug 22, 2024 ... A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a ... Dec 10, 2019 ... The InSet™ Total Shoulder System is used to treat significant disability in degenerative, rheumatoid, and traumatic disease of the glenohumeral ... Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... • Devices approved by the FDA through the Pre-Market Approval (PMA) process;. • Devices cleared by the FDA through the 510(k) process;. • FDA-approved ... Sep 19, 2023 ... The T2Biothreat Panel is a direct-from-blood molecular diagnostic test that runs on the FDA-cleared T2Dx® Instrument and simultaneously detects six biothreat ... The 510(k) pathway allows the clearance of a new medical device if the manufacturer shows that the device is substantially equivalent to one or more legally ... Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! 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) ...