FDA Device Intelligence
Home › SENSEONICS, INCORPORATED › Eversense E3 Insertion Tools Kit

Eversense E3 Insertion Tools Kit

SENSEONICS, INCORPORATED · Model FG-8300-01-201 · UDI-DI 00817491022905

QHJ Prescription
0
510(k) clearances
2,444
Adverse events
1
Recalls
8
Facilities

Description

Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.

Recalls

DateFirmReason
2019-09-18Senseonics, Inc.Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.