Clearance Summary
Disposable Intermittent Catheter (TPU Catheter) received FDA 510(k) clearance under submission number K243175, sponsored by Chengdu Daxan Innovative Medical Tech. 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 2025-06-26.
- Submission: K243175
- Applicant / Sponsor: Chengdu Daxan Innovative Medical Tech. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2025-06-26
Classification & Regulation
This clearance is catalogued under FDA product code EZD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.