Clearance Summary
Silicone Foley Catheter for single use received FDA 510(k) clearance under submission number K172807, sponsored by Changzhou Rongxin Medicine Minimal Invasion Technology. 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 2018-06-04.
- Submission: K172807
- Applicant / Sponsor: Changzhou Rongxin Medicine Minimal Invasion Technology
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2018-06-04
Classification & Regulation
This clearance is catalogued under FDA product code EZL and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.