Clearance Summary
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings received FDA 510(k) clearance under submission number K161897, sponsored by Kci USA, Inc. (Kinetic Concepts, 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 2016-10-04.
- Submission: K161897
- Applicant / Sponsor: Kci USA, Inc. (Kinetic Concepts, Inc.)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2016-10-04
Classification & Regulation
This clearance is catalogued under FDA product code OMP and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.