Niti-S SPAXUS Stent— 510(k) K252648
Substantially EquivalentTaewoong Medical Co., Ltd.
FDA 510(k) clearance K252648 for Niti-S SPAXUS Stent, Substantially Equivalent on 2026-03-13. Applicant: Taewoong Medical Co., Ltd.. Device class: 2.
Summary
Taewoong Medical's Niti-S SPAXUS Stent is filed under PCU, removable covered metallic pancreatic stents. The record doesn't list stent sizes.
Class II, 21 CFR 876.5015. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).
Taewoong Medical filed from Gyeonggi-Do, South Korea. The decision came 204 calendar days after receipt (August 21, 2025 to March 13, 2026).
Clearance details
- Applicant
- Taewoong Medical Co., Ltd.
- Product code
- Product code PCU
- Device class
- Class 2
- Regulation
- 21 CFR 876.5015
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gyeonggi-Do, KR
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More clearances from Taewoong Medical Co., Ltd.
view allAdverse events under product code PCU
product code PCU- Death
- 47
- Injury
- 804
- Malfunction
- 709
- Total
- 1,560
Source: openFDA MAUDE database, through . 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.