Name: Predicase
Price: 199 USD

K-number	K243619
Device name	Niti-S Esophageal Stent; Esophageal TTS Stent
Applicant	Taewoong Medical Co., Ltd.
Product code	ESW
Device class	Class II
Decision date	Oct 30, 2025
Decision	Substantially Equivalent
Regulation	878.3610

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Niti-S Esophageal Stent; Esophageal TTS Stent

Everything you need for a 510(k) submission. Nothing you don't.