Clearance Summary
THYROSAMPLER received FDA 510(k) clearance under submission number K062979, sponsored by Acd Medical Innovation Corp.. 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 2007-05-30.
- Submission: K062979
- Applicant / Sponsor: Acd Medical Innovation Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2007-05-30
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.