OTZ
5 FDA 510(k) clearances · Product code
442 daysmedian time to decision
683 days90th percentile
5clearances measured
FDA profile
- Official device name
- Graft Insertion Instrument For Endothelial Keratoplasty
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4300
- Medical specialty
- Ophthalmic
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| EndoSerter-PL (K203586) | Corneagen, Inc. | 2022-02-02 |
| EK DELIVERY DEVICE (K121579) | Tdak Medical, Inc. | 2012-10-03 |
| NCI SPATULA (K110734) | Fischer Surgical, Inc. | 2012-05-31 |
| TRIMOTION INJECTOR (K102999) | Kaneka Corp. | 2011-12-29 |
| ENDOSERTER (K090626) | Ocular Systems, Inc. | 2011-01-21 |
Track OTZ automatically
Every clearance here is in the API, with alerts when new ones post.