Clearance Summary
Single-use Ureteral Access Sheath received FDA 510(k) clearance under submission number K250695, sponsored by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2025-07-08.
- Submission: K250695
- Applicant / Sponsor: Shenzhen HugeMed Medical Technical Development Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2025-07-08
Classification & Regulation
This clearance is catalogued under FDA product code FED and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.