Clearance Summary
ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) received FDA 510(k) clearance under submission number K152702, sponsored by Ent Biotech Solutions. 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 2016-02-18.
- Submission: K152702
- Applicant / Sponsor: Ent Biotech Solutions
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2016-02-18
Classification & Regulation
This clearance is catalogued under FDA product code GEI and 21 CFR 878.4400, within the General, Plastic Surgery review panel as a Class II device.