Data / Medical devices / United States / Keranetics, Inc.
Keranetics, Inc.: FDA-registered device maker in Winston Salem, NC, United States, 2 510(k) clearances
Keranetics, Inc. is registered with the FDA (registration 3015980493) in Winston Salem, NC, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated July 16, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015980493
- Address
- 200 E 1st St Ste 102 Po Box 1, Winston Salem, NC, United States, 27101
- Owner or operator
- KeraNetics, Inc. (10061651)
- Roles
- Specification developer
- First device listed
- November 6, 2019
- Registered through
- 2026
- Brand names listed
- KeraStat Cream, KeraStat(R) Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 |
|---|---|---|---|---|---|---|
| July 16, 2020 | K192386 | KeraStat Cream | KGN | Substantially Equivalent | Keranetics | accessdata.fda.gov |
| June 2, 2017 | K162759 | KeraStat(R) Gel | KGN | Substantially Equivalent | Keranetics, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 16, 2020. 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.