DeviceClearance

Stelo Glucose Biosensor System— 510(k) K261359

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K261359 for Stelo Glucose Biosensor System, Substantially Equivalent on 2026-05-21. Applicant: Dexcom, Inc..

Clearance details

Applicant
Dexcom, Inc.
Product code
Code SAF
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code SAF

product code SAF
Injury
164
Malfunction
1,935
Total
2,099

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.