KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES— 510(k) K861629

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K861629 for KOMAI CT-STEREOTACTIC APPARATUS AND ACCESSORIES, Substantially Equivalent on 1986-08-12. Applicant: Downs Surgical , Ltd..

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: 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

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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.