www.fdanews.com/articles/209233-serpex-medical-recon-steerable-sheath-gets-510k-clearance
Serpex Medical Recon Steerable Sheath Gets 510(k) Clearance
September 1, 2022
Santa Clara, Calif.-based Serpex Medical has received 510(k) marketing clearance from the FDA for its Recon steerable sheath for use in pulmonary procedures.
The device is articulated at the distal tip, enabling physicians to access parts of the lung anatomy that are difficult to reach.
The steerable technology will allow for better precision while targeting difficult-to-reach lung nodules, especially those outside of the path that air follows to get into and out of the lungs.
The Recon sheath is Serpex Medical’s first steerable instrument to gain FDA’s clearance.