Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Graft Insertion Instrument For Endothelial Keratoplasty

FDA product code OTZ · 5 cleared devices

Class 1 Ophthalmic
Regulation
21 CFR 886.4300
Review panel
OP
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-01-21 – 2022-02-02

A graft insertion device for endothelial keratoplasty is a device intended to be inserted into the eye during surgery to direct the insertion of a corneal graft and be removed after insertion is completed.

↑