K261359
- 510(k) number
- K261359
- Device name
- Stelo Glucose Biosensor System
- Applicant
- Dexcom, Inc. CA · US
- Product code
- SAF — Integrated Continuous Glucose Monitor For Non-Intens
- Decision date
- 2026-05-21
- Date received
- 2026-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K261359.pdf
Official FDA record: K261359
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.