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Eversense Insertion Tools Kit

SENSEONICS, INCORPORATED · Model FG-8402-01-201 · UDI-DI 00817491024336

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

Description

Eversense Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and a paper insert on the electronic instructions for use.

Recalls

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

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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.