What are the post-market surveillance requirements for devices cleared through the 510(k) process?

The US Food and Drug Administration (FDA) cleared the disc via the 510(k) pathway, which does not require clinical testing data. Instead, clearance is based on ... Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... 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 ... ... 510(k) process; the agency gives the nod for them to be marketed in the U.S. Please note that FDA approval and FDA clearance mean the same. Premarket ... Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the ... 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, ... Apr 17, 2025 ... Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy. Feb 8, 2024 ... For comparison, the FDA mean review times were 150 days for 510(k)s ... And the 510(k) clearance pathway is generally easier and faster. May 21, 2017 ... Soterix Medical is the world leader in non-invasive neuromodulation and brain stimulation technology. Researchers and clinicians choose ... Pending 510(k) clearance, not available for sale within the United States. Check out our next-generation MRI!! Page 11. □ “FDA does not intend to object to” ...