Clearance Summary
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing received FDA 510(k) clearance under submission number K162159, sponsored by Vr Medical Technologies, 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 2017-04-28.
- Submission: K162159
- Applicant / Sponsor: Vr Medical Technologies, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2017-04-28
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.