Regulation
FDA grants 510(k) clearance to TaeWoong Medical for Spaxus EUS stent
TaeWoong Medical received FDA 510(k) clearance for the Niti-S Spaxus Stent, an endoscopic ultrasound (EUS)-guided therapeutic stent. The clearance enables US commercialization and expands the company's portfolio of EUS-guided interventional solutions for gastroenterology and related specialties.
The source
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