Clearance Summary
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) received FDA 510(k) clearance under submission number K203183, sponsored by Bolder Surgical, LLC. 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 2021-05-06.
- Submission: K203183
- Applicant / Sponsor: Bolder Surgical, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4400
- Decision date: 2021-05-06
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.