# QHJ · Sensor, Glucose, Implanted, Non-Adjunctive Use

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/QHJ

## Overview

- **Product Code:** QHJ
- **Device Name:** Sensor, Glucose, Implanted, Non-Adjunctive Use
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

A non-adjunctive implanted glucose sensor is intended to determine glucose   levels, and the direction and rate of change of glucose levels in people with   diabetes. The device is indicated to replace information obtained from standard   blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P160048S021](/device/P160048S021.md) | Eversense® E3 Continuous Glucose Monitoring (CGM) System | Senseonics, Incorporated | Mar 29, 2023 | APPR |
| [P160048S016](/device/P160048S016.md) | Eversense® E3 Continuous Glucose Monitoring System | Senseonics, Incorporated | Feb 10, 2022 | APPR |
| [P160048S006](/device/P160048S006.md) | Eversense Continuous Glucose Monitoring System | Senseonics, Incorporated | Jun 6, 2019 | APPR |

## Top Applicants

- Senseonics, Incorporated — 3 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/QHJ](https://fda-staging.innolitics.com/productcode/QHJ)

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