Clearance Summary
GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP received FDA 510(k) clearance under submission number K897119, sponsored by Grieshaber & Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1990-04-12.
- Submission: K897119
- Applicant / Sponsor: Grieshaber & Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.3100
- Decision date: 1990-04-12
Classification & Regulation
This clearance is catalogued under FDA product code HQW and 21 CFR 886.3100, within the Ophthalmic review panel as a Class II device.