Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300) → OTZ — Graft Insertion Instrument For Endothelial Keratoplasty

# OTZ · Graft Insertion Instrument For Endothelial Keratoplasty

_Ophthalmic · 21 CFR 886.4300 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/OTZ

## Overview

- **Product Code:** OTZ
- **Device Name:** Graft Insertion Instrument For Endothelial Keratoplasty
- **Regulation:** [21 CFR 886.4300](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4300)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

## Classification Rationale

Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Recent Cleared Devices (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K203586](/device/K203586.md) | EndoSerter-PL | Corneagen, Inc. | Feb 2, 2022 | SESE |
| [K121579](/device/K121579.md) | EK DELIVERY DEVICE | Tdak Medical, Inc. | Oct 3, 2012 | SESE |
| [K110734](/device/K110734.md) | NCI SPATULA | Fischer Surgical, Inc. | May 31, 2012 | SESE |
| [K102999](/device/K102999.md) | TRIMOTION INJECTOR | Kaneka Corp. | Dec 29, 2011 | SESE |
| [K090626](/device/K090626.md) | ENDOSERTER | Ocular Systems, Inc. | Jan 21, 2011 | SESE |

## Top Applicants

- Corneagen, Inc. — 1 clearance
- Fischer Surgical, Inc. — 1 clearance
- Kaneka Corp. — 1 clearance
- Ocular Systems, Inc. — 1 clearance
- Tdak Medical, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/OTZ](https://fda.innolitics.com/productcode/OTZ)

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