Clearance Summary
CM005 Standard (CM005); CM004 Mini (CM004) received FDA 510(k) clearance under submission number K233458, sponsored by Connexicon Medical , Ltd.. 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 2024-07-15.
- Submission: K233458
- Applicant / Sponsor: Connexicon Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4010
- Decision date: 2024-07-15
Classification & Regulation
This clearance is catalogued under FDA product code MPN and 21 CFR 878.4010, within the General, Plastic Surgery review panel as a Class II device.