Clearance Summary
PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX received FDA 510(k) clearance under submission number K082805, sponsored by Q Urological Corporation. 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 2010-01-20.
- Submission: K082805
- Applicant / Sponsor: Q Urological Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4620
- Decision date: 2010-01-20
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.