Niti-S Esophageal Stent; Esophageal TTS Stent— 510(k) K243619

Substantially Equivalent

Taewoong Medical Co., Ltd.

FDA 510(k) clearance K243619 for Niti-S Esophageal Stent; Esophageal TTS Stent, Substantially Equivalent on 2025-10-30. Applicant: Taewoong Medical Co., Ltd..

Clearance details

Applicant: Taewoong Medical Co., Ltd.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2024-11-22
Decision date: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code ESW

product code ESW

Death: 11
Injury: 353
Malfunction: 442
Total: 806

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.