K861629

Substantially Equivalent

KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES

Applicant: Downs Surgical , Ltd.
Product code: HAW
Advisory panel: Neurology
Date received: 1986-04-29
Decision date: 1986-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

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.