Clearance Summary
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr received FDA 510(k) clearance under submission number K211032, sponsored by Urogen Pharma, 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 2021-11-19.
- Submission: K211032
- Applicant / Sponsor: Urogen Pharma, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2021-11-19
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.