FDA Product Code
FDA Product Code OTZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4300
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203586 | EndoSerter-PL | Corneagen, Inc. | 2022-02-02 | Traditional | PDF ↗ |
| K121579 | EK DELIVERY DEVICE | Tdak Medical, Inc. | 2012-10-03 | Traditional | PDF ↗ |
| K110734 | NCI SPATULA | Fischer Surgical, Inc. | 2012-05-31 | Traditional | PDF ↗ |
| K102999 | TRIMOTION INJECTOR | Kaneka Corp. | 2011-12-29 | Traditional | PDF ↗ |
| K090626 | ENDOSERTER | Ocular Systems, Inc. | 2011-01-21 | Traditional | PDF ↗ |
Product code OTZ · Class I · Ophthalmic. Data: openFDA.