SURGICASE GUIDE— 510(k) K111558

Substantially Equivalent

Materialise NV

FDA 510(k) clearance K111558 for SURGICASE GUIDE, Substantially Equivalent on 2012-03-27. Applicant: Materialise NV.

Clearance details

Applicant: Materialise NV
Product code: Code HAW
Advisory panel: Neurology
Date received: 2011-06-03
Decision date: 2012-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leuven, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.