Y-MIC— 510(k) K161639

Substantially Equivalent

Micron Corporation

FDA 510(k) clearance K161639 for Y-MIC, Substantially Equivalent on 2016-12-22. Applicant: Micron Corporation.

Clearance details

Applicant: Micron Corporation
Product code: Code ELC
Advisory panel: Dental
Date received: 2016-06-14
Decision date: 2016-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ota-Ku, Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.