OTZ

Graft Insertion Instrument For Endothelial Keratoplasty

Product code

OTZ

Device name

Graft Insertion Instrument For Endothelial Keratoplasty

Device class

Class 1

21 CFR

21 CFR 886.4300

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).