Cranial PSI— 510(k) K161090

Substantially Equivalent

Ossdsign AB

FDA 510(k) clearance K161090 for Cranial PSI, Substantially Equivalent on 2017-01-19. Applicant: Ossdsign AB.

Clearance details

Applicant: Ossdsign AB
Product code: Code GXN
Advisory panel: Neurology
Date received: 2016-04-18
Decision date: 2017-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.