Data / Medical devices / United States / CorneaGen
CorneaGen: FDA-registered device maker in Winston Salem, NC, United States, 2 510(k) clearances
CorneaGen is registered with the FDA (registration 3005357288) in Winston Salem, NC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 2, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005357288
- Address
- 101 N Chestnut St Ste 303, Winston Salem, NC, United States, 27101
- Owner or operator
- CorneaGen (10046718)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 2, 2014
- Registered through
- 2026
- Brand names listed
- Pre-Loaded EndoSerter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Graft Insertion Instrument For Endothelial Keratoplasty | OTZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 2, 2022 | K203586 | EndoSerter-PL | OTZ | Substantially Equivalent | Corneagen, Inc. | accessdata.fda.gov |
| January 21, 2011 | K090626 | ENDOSERTER | OTZ | Substantially Equivalent | Ocular Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated February 2, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.