FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent

TaeWoong Medical has secured the US FDA clearance to commercialise the Niti-S Spaxus Stent, expanding its range of EUS-guided therapeutic solutions. TaeWoong Medical, the fully covered, self-expanding metallic device, is intended to aid EUS drainage procedures. The SPAXUS Stent is indicated for gallbladder drainage in patients with acute cholecystitis who are considered high risk for surgery. Credit: Beloborod/Shutterstock.com. US-based TaeWoong Medical has secured the US Food and Drug Administration (FDA) clearance to commercialise the Niti-S Spaxus Stent, expanding its range of endoscopic ultrasound (EUS)-guided therapeutic solutions. The regulatory decision allows the stent to be marketed within the US after the…

Source: Medical Device Network