Clearance Summary
URASSIST received FDA 510(k) clearance under submission number K062061, sponsored by Preferred Medical Devices, Inc.. 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 2006-10-05.
- Submission: K062061
- Applicant / Sponsor: Preferred Medical Devices, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 2006-10-05
Classification & Regulation
This clearance is catalogued under FDA product code NZU and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.