510(k) K211706

Esophageal TTS Stent by Taewoong Medical Co., Ltd. — Product Code ESW

K211706 is an FDA 510(k) premarket notification submitted by Taewoong Medical Co., Ltd. for the device "Esophageal TTS Stent". The FDA issued a decision of Substantially Equivalent on October 8, 2021. The device falls under product code ESW (Prosthesis, Esophageal), a Class II device regulated under 21 CFR 878.3610. Taewoong Medical Co., Ltd. has at least 10 other 510(k) clearances on record.