Clearance Summary
GORE SEAMGUARD Reinforcement received FDA 510(k) clearance under submission number K150551, sponsored by W. L. Gore & Associates, Inc.. 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 2015-03-30.
- Submission: K150551
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2015-03-30
Classification & Regulation
This clearance is catalogued under FDA product code OXC and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.