EnVisio Navigation Sytem— 510(k) K183400

Substantially Equivalent

Elucent Medical, Inc.

FDA 510(k) clearance K183400 for EnVisio Navigation Sytem, Substantially Equivalent on 2019-03-22. Applicant: Elucent Medical, Inc..

Clearance details

Applicant: Elucent Medical, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2018-12-07
Decision date: 2019-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.