Clearance Summary
Isolator® Linear Pen (MLP1); Isolator® Transpolar Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1) received FDA 510(k) clearance under submission number K221358, 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 2022-12-30.
- Submission: K221358
- Applicant / Sponsor: AtriCure, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2022-12-30
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.