6 premarket notifications (510(k)s) from applicants based in South Carolina were decided by FDA in the last 12 months, newest first. Each row links to FDA's own record.
| Decided | Applicant | Device | Area | Where | Record |
|---|---|---|---|---|---|
| 2026-06-26 | ElectroWire Medical | LightningWire Transseptal Puncture System (TPS) DXF | Cardiovascular | Lexington, South Carolina | K261745 |
| 2026-05-27 | Glytec, LLC | Glucommander NDC | Anesthesiology | Greenville, South Carolina | K254102 |
| 2026-05-14 | Koncept Innovators, Inc. | Dormiva Anti-Snoring Mouth Guard LRK | Dental | Myrtle Beach, South Carolina | K261134 |
| 2026-02-19 | Erchonia Corporation | Erchonia DPN Laser (Model# EVRL) NHN | Physical Medicine | Fountain Inn, South Carolina | K251903 |
| 2025-12-15 | Erchonia Corporation | Erchonia CLX (Model # CFL) OLI | General, Plastic Surgery | Fountain Inn, South Carolina | K252574 |
| 2025-12-08 | Degen Medical | DeGen Medical Patient Specific Implant (PSI) System OVD | Orthopedic | Florence, South Carolina | K251829 |
Where this comes from
Before most medical devices can be sold in the United States, the maker submits a premarket notification, a 510(k), and FDA decides whether the device is substantially equivalent to one already on the market. Every row here is one of those decisions, linked to FDA's own record of it. The product area is the medical specialty FDA files the device under; the location is the applicant's, as the submission gives it.
A clearance means the agency found the device substantially equivalent; it is not an endorsement. Where an applicant also files with the SEC under the same name in the same state, it links to that company's page.
Cite this page
https://mentionfox.com/fda/510k/state/sc