510(k) K252648
K252648 is an FDA 510(k) premarket notification submitted by Taewoong Medical Co., Ltd. for the device "Niti-S SPAXUS Stent". The FDA issued a decision of Substantially Equivalent on March 13, 2026. The device falls under product code PCU (Pancreatic Stent, Covered, Metallic, Removable), a Class II device regulated under 21 CFR 876.5015. Taewoong Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2026
- Date Received
- August 21, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pancreatic Stent, Covered, Metallic, Removable
- Device Class
- Class II
- Regulation Number
- 876.5015
- Review Panel
- GU
- Submission Type
To facilitate transmural endoscopic drainage of pancreatic pseudocysts