Clearance Summary
FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS received FDA 510(k) clearance under submission number K140588, sponsored by Stryker Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2014-06-26.
- Submission: K140588
- Applicant / Sponsor: Stryker Corporation
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 2014-06-26
Classification & Regulation
This clearance is catalogued under FDA product code FXY and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.