K141644

Substantially Equivalent

INNOVASIS CRANIAL SYSTEM

Applicant: Innovasis, Inc.
Product code: GWO
Advisory panel: Neurology
Date received: 2014-06-19
Decision date: 2014-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Adverse events under product code GWO

product code GWO

Malfunction: 583
Total: 583

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.