Clearance Summary
Edwards Suture Fastening System received FDA 510(k) clearance under submission number K150882, sponsored by Edwards Lifesciences, 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 2015-06-16.
- Submission: K150882
- Applicant / Sponsor: Edwards Lifesciences, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2015-06-16
Classification & Regulation
This clearance is catalogued under FDA product code HCF and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.