Clearance Summary
Ellipse Supplemental Instrument Trays received FDA 510(k) clearance under submission number K151594, sponsored by Ellipse Technologies, Incorporated. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-01-25.
- Submission: K151594
- Applicant / Sponsor: Ellipse Technologies, Incorporated
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2016-01-25
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.