OTZ · Graft Insertion Instrument For Endothelial Keratoplasty
Ophthalmic · 21 CFR 886.4300 · Class 1
Overview
| Product Code | OTZ |
|---|---|
| Device Name | Graft Insertion Instrument For Endothelial Keratoplasty |
| Regulation | 21 CFR 886.4300 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203586 | EndoSerter-PL | Corneagen, Inc. | Feb 2, 2022 | SESE |
| K121579 | EK DELIVERY DEVICE | Tdak Medical, Inc. | Oct 3, 2012 | SESE |
| K110734 | NCI SPATULA | Fischer Surgical, Inc. | May 31, 2012 | SESE |
| K102999 | TRIMOTION INJECTOR | Kaneka Corp. | Dec 29, 2011 | SESE |
| K090626 | ENDOSERTER | Ocular Systems, Inc. | Jan 21, 2011 | SESE |
Top Applicants
- Tdak Medical, Inc. — 1 clearance
- Ocular Systems, Inc. — 1 clearance
- Kaneka Corp. — 1 clearance
- Fischer Surgical, Inc. — 1 clearance
- Corneagen, Inc. — 1 clearance
