EndoSerter-PL
510(k) K203586
EndoSerter-PL is a Class I device made by Corneagen, Inc., cleared under FDA 510(k) K203586 on 2 Feb 2022 and registered in EUDAMED, active as of 9 Oct 2026.
Active
CE MDD 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK203586 | Date2 Feb 2022 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K203586 decided 2 Feb 2022 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- OTZ
- Device class
- Class I
- Regulation
- 21 CFR Part 886.4300
- Advisory committee
- Ophthalmic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K203586
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| EndoSerter-PL ES-PL | ES-PL | 00855934007485 | — | On the market |
Similar devices
Other devices filed under FDA product code OTZ (Graft Insertion Instrument For Endothelial Keratoplasty).