K250585
- 510(k) number
- K250585
- Device name
- LumenaTM Ureteral Access Sheath
- Applicant
- Cathegenix (Xiamen) Co., Ltd. CN
- Product code
- FED — Endoscopic Access Overtube, Gastroenterology-Urology
- Decision date
- 2025-06-27
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K250585.pdf
Official FDA record: K250585
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.