Clearance Summary
GORE SPHEREX IMPLANT received FDA 510(k) clearance under submission number K962241, sponsored by W. L. Gore & Associates, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1996-08-22.
- Submission: K962241
- Applicant / Sponsor: W. L. Gore & Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3320
- Decision date: 1996-08-22
Classification & Regulation
This clearance is catalogued under FDA product code HPZ and 21 CFR 886.3320, within the Ophthalmic review panel as a Class II device.