Cleared Special

Esophageal TTS Stent

K240522 · Taewoong Medical · Gastroenterology & Urology

Mar 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K240522 is an FDA 510(k) clearance for the Esophageal TTS Stent, a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by Taewoong Medical (Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 22, 2024, 28 days after receiving the submission on February 23, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number	K240522 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2024
Decision Date	March 22, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF