Clearance Summary
APEXUM ABLATOR received FDA 510(k) clearance under submission number K082325, sponsored by Apexum , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2009-04-21.
- Submission: K082325
- Applicant / Sponsor: Apexum , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2009-04-21
Classification & Regulation
This clearance is catalogued under FDA product code EKX and 21 CFR 872.4200, within the Dental review panel as a Class I device.