Clearance Summary
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) received FDA 510(k) clearance under submission number K170233, sponsored by Zhanjiang Star Enterprise 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 2017-10-13.
- Submission: K170233
- Applicant / Sponsor: Zhanjiang Star Enterprise Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2017-10-13
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.