Clearance Summary
GORE BIO-A Tissue Reinforcement received FDA 510(k) clearance under submission number K191773, 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 2019-07-31.
- Submission: K191773
- 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: 2019-07-31
Classification & Regulation
This clearance is catalogued under FDA product code OWT and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.