Clearance Summary
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 received FDA 510(k) clearance under submission number K101174, sponsored by AtriCure, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2010-11-12.
- Submission: K101174
- Applicant / Sponsor: AtriCure, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2010-11-12
Classification & Regulation
This clearance is catalogued under FDA product code OCL and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.