Clearance Summary
GAYHEART CORNEAL EXCISION DEVICE received FDA 510(k) clearance under submission number K022843, sponsored by Stephens Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-11-01.
- Submission: K022843
- Applicant / Sponsor: Stephens Instruments
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 2002-11-01
Classification & Regulation
This clearance is catalogued under FDA product code HRH and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.