Clearance Summary
SCLERAL PLUGS, 19 AND 20 GAUGE received FDA 510(k) clearance under submission number K990872, sponsored by Ophthalmic Consultants, 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 1999-07-13.
- Submission: K990872
- Applicant / Sponsor: Ophthalmic Consultants, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4155
- Decision date: 1999-07-13
Classification & Regulation
This clearance is catalogued under FDA product code LXP and 21 CFR 886.4155, within the Ophthalmic review panel as a Class II device.