Niti-S SPAXUS Stent
FDA 510(k) clearance K252648 · decided 2026-03-13
Clearance details
- K-number
- K252648
- Device name
- Niti-S SPAXUS Stent
- Applicant
- Taewoong Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-21
- Decision date
- 2026-03-13
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- PCU
- Device class
- 2
- Regulation number
- 876.5015
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gyeonggi-Do, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.