Stelo Glucose Biosensor System— 510(k) K260935

Substantially Equivalent

Dexcom, Inc.

FDA 510(k) clearance K260935 for Stelo Glucose Biosensor System, Substantially Equivalent on 2026-06-12. Applicant: Dexcom, Inc..

Clearance details

Applicant: Dexcom, Inc.
Product code: Code SBH
Advisory panel: Clinical Chemistry
Date received: 2026-03-20
Decision date: 2026-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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