Clearance Summary
UreTron PF Series Probe received FDA 510(k) clearance under submission number K162119, sponsored by Med-Sonics Corp.. 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 2016-08-29.
- Submission: K162119
- Applicant / Sponsor: Med-Sonics Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4480
- Decision date: 2016-08-29
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.