Clearance Summary
URETRON MODEL URT received FDA 510(k) clearance under submission number K111058, sponsored by Med-Sonics Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2012-03-30.
- Submission: K111058
- Applicant / Sponsor: Med-Sonics Corp.
- Clearance pathway: Abbreviated
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 2012-03-30
Classification & Regulation
This clearance is catalogued under FDA product code FFK and 21 CFR 876.4480, within the Gastroenterology, Urology review panel as a Class II device.