Clearance Summary
pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent received FDA 510(k) clearance under submission number K163068, sponsored by Q Urological Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2016-12-22.
- Submission: K163068
- Applicant / Sponsor: Q Urological Corporation
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4620
- Decision date: 2016-12-22
Classification & Regulation
This clearance is catalogued under FDA product code FAD and 21 CFR 876.4620, within the Gastroenterology, Urology review panel as a Class II device.