March 2015

kBLASTER update March 2015: 510(k) search for predicates and successful 510(k) clearance strategy

The kBLASTER database has been updated today with FDA 510(k) clearances from February 2015 and FDA 510(k) splash pages for 510(k)s clearances in March 2015. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will see blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s).  With more than 60,000 510(k)...

Gauss Surgical Announces FDA 510(k) Clearance of Triton Canister App for Accurate Surgical Blood Loss Monitoring

Los Altos, Calif., March 16, 2015 – Gauss Surgical today announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Triton Canister App, the second core product in its Triton System™ portfolio, the world’s first and only mobile platform for real-time monitoring of surgical blood loss. Now, in addition to estimating blood loss on surgical sponges, the system can accurately estimate blood...