510(k) K251469
K251469 is an FDA 510(k) premarket notification submitted by Cathegenix (Xiamen) Co., Ltd. for the device "Endura Ureteral Stent and Stent Set". The FDA issued a decision of Substantially Equivalent (kit) on December 19, 2025. The device falls under product code FAD (Stent, Ureteral), a Class II device regulated under 21 CFR 876.4620. Cathegenix (Xiamen) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 19, 2025
- Date Received
- May 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Ureteral
- Device Class
- Class II
- Regulation Number
- 876.4620
- Review Panel
- GU
- Submission Type