FDA product code OTZ: Graft Insertion Instrument For Endothelial Keratoplasty
OTZ is the FDA product code for graft insertion instrument for endothelial keratoplasty. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under OTZ, 1 in the last five years, from 5 different applicants. The average 510(k) review took 424 days (median 442).
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.
Classification
| Field | Value |
|---|---|
| Device name | Graft Insertion Instrument For Endothelial Keratoplasty |
| Device class | Class I |
| Regulation | 21 CFR 886.4300 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for OTZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 421 |
Compare with all 510(k) review times · Search every OTZ clearance
Top OTZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Corneagen, Inc. | 1 | 2022-02-02 |
| Tdak Medical, Inc. | 1 | 2012-10-03 |
| Fischer Surgical, Inc. | 1 | 2012-05-31 |
| Kaneka Corp. | 1 | 2011-12-29 |
| Ocular Systems, Inc. | 1 | 2011-01-21 |
Most recent OTZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203586 | Corneagen, Inc. | EndoSerter-PL | 2022-02-02 | 421 |
| K121579 | Tdak Medical, Inc. | EK DELIVERY DEVICE | 2012-10-03 | 126 |
| K110734 | Fischer Surgical, Inc. | NCI SPATULA | 2012-05-31 | 442 |
| K102999 | Kaneka Corp. | TRIMOTION INJECTOR | 2011-12-29 | 447 |
| K090626 | Ocular Systems, Inc. | ENDOSERTER | 2011-01-21 | 683 |
Recalls for OTZ devices
openFDA lists no recalls for product code OTZ.
Frequently asked questions
What is FDA product code OTZ?
OTZ is the FDA product code for graft insertion instrument for endothelial keratoplasty. It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel.
What device class is OTZ?
Class I, regulation 21 CFR 886.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OTZ?
Across 5 cleared submissions the average was 424 days from receipt to decision (median 442).
Which companies have the most OTZ clearances?
Corneagen, Inc. (1); Tdak Medical, Inc. (1); Fischer Surgical, Inc. (1); Kaneka Corp. (1); Ocular Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OTZ
- Run a recall and safety report across every OTZ manufacturer
- Watch product code OTZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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