Stelo Glucose Biosensor System— 510(k) K234070
Substantially EquivalentDexcom, Inc.
FDA 510(k) clearance K234070 for Stelo Glucose Biosensor System, Substantially Equivalent on 2024-03-05. Applicant: Dexcom, Inc.. Device class: 2.
Clearance details
- Applicant
- Dexcom, Inc.
- Product code
- Code SAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code SAF
view allMore clearances from Dexcom, Inc.
view all- K262472 — Stelo Glucose Biosensor System
- K260935 — Stelo Glucose Biosensor System
- K261402 — Dexcom G7 Continuous Glucose Monitoring System; Dexcom G7 15 Day Continuous Glucose Monitoring System
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
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.