# Graft Insertion Instrument For Endothelial Keratoplasty
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OTZ)
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