OTZ — Graft Insertion Instrument For Endothelial Keratoplasty Class I
FDA product code OTZ covers "Graft Insertion Instrument For Endothelial Keratoplasty", a Class I medical device regulated under 21 CFR 886.4300. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OTZ
- Device Class
- Class I
- Regulation Number
- 886.4300
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203586 | corneagen | EndoSerter-PL | February 2, 2022 |
| K121579 | tdak medical | EK DELIVERY DEVICE | October 3, 2012 |
| K110734 | fischer surgical | NCI SPATULA | May 31, 2012 |
| K102999 | kaneka | TRIMOTION INJECTOR | December 29, 2011 |
| K090626 | ocular systems | ENDOSERTER | January 21, 2011 |