SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION— 510(k) K010542

Substantially Equivalent

Surgical Navigation Specialists, Inc.

FDA 510(k) clearance K010542 for SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION, Substantially Equivalent on 2001-05-08. Applicant: Surgical Navigation Specialists, Inc..

Clearance details

Applicant: Surgical Navigation Specialists, Inc.
Product code: Code HAW
Advisory panel: Neurology
Date received: 2001-02-23
Decision date: 2001-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga Ontario, CA

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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.