Leo Minor— 510(k) K142984

Substantially Equivalent

Sunnex, Inc.

FDA 510(k) clearance K142984 for Leo Minor, Substantially Equivalent on 2014-10-29. Applicant: Sunnex, Inc..

Clearance details

Applicant: Sunnex, Inc.
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2014-10-16
Decision date: 2014-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

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Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.