Clearance Summary
PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM received FDA 510(k) clearance under submission number K112458, sponsored by Medica-Rents Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-01-05.
- Submission: K112458
- Applicant / Sponsor: Medica-Rents Co., Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2012-01-05
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.