GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION— 510(k) K931991

Substantially Equivalent

Nomos Corp.

FDA 510(k) clearance K931991 for GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION, Substantially Equivalent on 1993-08-20. Applicant: Nomos Corp..

Clearance details

Applicant: Nomos Corp.
Product code: Code HAW
Advisory panel: Neurology
Date received: 1993-04-22
Decision date: 1993-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Miami, FL, 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.