Niti-S SPAXUS Stent— 510(k) K252648

Substantially Equivalent

Taewoong Medical Co., Ltd.

FDA 510(k) clearance K252648 for Niti-S SPAXUS Stent, Substantially Equivalent on 2026-03-13. Applicant: Taewoong Medical Co., Ltd..

Clearance details

Applicant: Taewoong Medical Co., Ltd.
Product code: Code PCU
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-21
Decision date: 2026-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code PCU

product code PCU

Death: 47
Injury: 804
Malfunction: 709
Total: 1,560

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.