510(k) K261359 ยท SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Stelo Glucose Biosensor System
| Applicant | Dexcom, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 21, 2026 |
| Received | Apr 24, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261359
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.