Clearance Summary
SurgiMend PRS Meshed, Revize-X received FDA 510(k) clearance under submission number K171357, sponsored by Integra Lifesciences Corporation (Owner of Tei Biosciences). 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 2017-06-07.
- Submission: K171357
- Applicant / Sponsor: Integra Lifesciences Corporation (Owner of Tei Biosciences)
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2017-06-07
Classification & Regulation
This clearance is catalogued under FDA product code OXH and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.