What are the common statistical deficiencies identified in 510(k) applications?

Jul 29, 2024 ... The FDA's action means that SPIRA-A Integrated is now indicated for use at one or more levels, from L1-S1 as an adjunct to fusion in skeletally ... Jun 26, 2018 ... A myth that has regrettably gained some traction lately is that the FDA's clearance of a medical device under the 510(k) substantial ... A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. Jun 5, 2024 ... A legally marketed predicate means the device has previously gone through a 510(k) clearance process and obtained FDA clearance or was on the ... Dec 30, 2024 ... SIMEOX 200 is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as ... 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 ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. ... The phrase “substantially equivalent” means your ... FDA clearance through the 510(k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously 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 ...