Leaderflex Mini and Leaderflex Nano— 510(k) K212370

Substantially Equivalent

Vygon USA

FDA 510(k) clearance K212370 for Leaderflex Mini and Leaderflex Nano, Substantially Equivalent on 2022-08-29. Applicant: Vygon USA.

Clearance details

Applicant: Vygon USA
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2021-07-30
Decision date: 2022-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale Montgomery, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.