Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Glytec, LLC with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 5, 2026: Glucommander.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 5, 2026 | GlucommanderK261939 · NDC | 510(k) clearances |
| May 27, 2026 | GlucommanderK254102 · NDC | 510(k) clearances |
| Aug 4, 2017 | GlucommanderK152300 · NDC | 510(k) clearances |
| May 8, 2012 | G+ SYSTEMK113853 · NDC | 510(k) clearances |
| Jun 28, 2010 | G+ SYSTEMK101344 · NDC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
