Clearance Summary
EVICEL APPLICATION DEVICE received FDA 510(k) clearance under submission number K090162, sponsored by Omrix Biopharmaceuticals , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2009-02-20.
- Submission: K090162
- Applicant / Sponsor: Omrix Biopharmaceuticals , Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5860
- Decision date: 2009-02-20
Classification & Regulation
This clearance is catalogued under FDA product code FMF and 21 CFR 880.5860, within the General Hospital review panel as a Class II device.