K203586 is an FDA 510(k) clearance for the EndoSerter-PL. This device is classified as a Graft Insertion Instrument For Endothelial Keratoplasty (Class I - General Controls, product code OTZ).
Submitted by Corneagen, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 2, 2022, 421 days after receiving the submission on December 8, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4300. 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..
| 510(k) Number | K203586 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2020 |
| Decision Date | February 02, 2022 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OTZ - Graft Insertion Instrument For Endothelial Keratoplasty |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4300 |
| 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. |