Clearance Summary
GORE REVOX THYROPLASTY IMPLANT received FDA 510(k) clearance under submission number K983525, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1998-12-10.
- Submission: K983525
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 1998-12-10
Classification & Regulation
This clearance is catalogued under FDA product code MIX and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.