Clearance Summary
Alcyone MEMS Cannula (AMC) System received FDA 510(k) clearance under submission number K150660, sponsored by Alcyone Lifesciences, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-04-16.
- Submission: K150660
- Applicant / Sponsor: Alcyone Lifesciences, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4060
- Decision date: 2015-04-16
Classification & Regulation
This clearance is catalogued under FDA product code HCD and 21 CFR 882.4060, within the Neurology review panel as a Class I device.