Clearance Summary
V.A.C.ULTA Negative Pressure Wound Therapy System received FDA 510(k) clearance under submission number K162790, 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 2017-01-26.
- Submission: K162790
- 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: 2017-01-26
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.