Data / Medical devices / United States / Senseonics, Inc.
Senseonics, Inc.: FDA-registered device maker in Germantown, MD, United States, 1 510(k) clearance
Senseonics, Inc. is registered with the FDA (registration 3009862700) in Germantown, MD, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 16, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009862700
- Address
- 20451 Seneca Meadows Pkwy, Germantown, MD, United States, 20876
- Owner or operator
- Senseonics, Inc. (10044307)
- Roles
- Manufacturer
- First device listed
- July 3, 2018
- Registered through
- 2026
- Brand names listed
- Eversense 365 Continuous Glucose Monitoring (CGM) System, Eversense Data Management System (DMS and DMS Pro), Eversense NOW Application
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | 1 | Manufacturer | accessdata.fda.gov |
| Continuous Glucose Monitor Secondary Display | PJT | 2 | Manufacturer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate | SBA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2024 | K241335 | Eversense 365 Continuous Glucose Monitoring (CGM) System | SBA | Substantially Equivalent | Senseonics, Incorporated | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 18, 2019 | 83896 | Class II | Terminated | Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor | Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Glucose Monitor Retrospective Data Analysis Software
- All makers of Continuous Glucose Monitor Secondary Display
Updated September 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.