Product code
OTZ: Graft insertion instrument for endothelial keratoplasty
FDA product code · Class I · Ophthalmic
Key facts
| Product code | OTZ |
|---|---|
| Device | Graft insertion instrument for endothelial keratoplasty |
| Device class | Class I |
| Regulation number | 886.4300 |
| Review panel | Ophthalmic |
| Medical specialty | Ophthalmic |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database