Clearance Summary
ATLAAS (Atraumatic Left Atrial Appendage System) (AD) received FDA 510(k) clearance under submission number K252917, sponsored by Genesee Biomedical, 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 2026-05-22.
- Submission: K252917
- Applicant / Sponsor: Genesee Biomedical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2026-05-22
Classification & Regulation
This clearance is catalogued under FDA product code PZX and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.