microINR System— 510(k) K201185

Substantially Equivalent

Iline Microsystems, S.L.

FDA 510(k) clearance K201185 for microINR System, Substantially Equivalent on 2020-12-18. Applicant: Iline Microsystems, S.L..

Clearance details

Applicant: Iline Microsystems, S.L.
Product code: Code GJS
Advisory panel: Hematology
Date received: 2020-05-01
Decision date: 2020-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Sebastian-Donostia, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.