Clearance Summary
RENASYS Touch; RENASYS Y-Connector received FDA 510(k) clearance under submission number K181822, sponsored by Smith & Nephew Medical Limited. 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 2019-03-21.
- Submission: K181822
- Applicant / Sponsor: Smith & Nephew Medical Limited
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2019-03-21
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.