Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent— 510(k) K250663

Substantially Equivalent

Taewoong Medical Co., Ltd.

FDA 510(k) clearance K250663 for Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent, Substantially Equivalent on 2025-03-31. Applicant: Taewoong Medical Co., Ltd..

Clearance details

Applicant: Taewoong Medical Co., Ltd.
Product code: Code MUM
Advisory panel: General, Plastic Surgery
Date received: 2025-03-05
Decision date: 2025-03-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUM

product code MUM

Death: 6
Injury: 137
Total: 143

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.