Graft Insertion Instrument For Endothelial Keratoplasty
OTZ · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.4300
Classification
FDA Product Code
OTZ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.4300
Review panel
OP
Medical specialty
Ophthalmic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.