CLARUS NEUROPEN MODEL 2120— 510(k) K942249

Substantially Equivalent

Clarus Medical Systems, Inc.

FDA 510(k) clearance K942249 for CLARUS NEUROPEN MODEL 2120, Substantially Equivalent on 1994-11-04. Applicant: Clarus Medical Systems, Inc..

Clearance details

Applicant: Clarus Medical Systems, Inc.
Product code: Code GWG
Advisory panel: Neurology
Date received: 1994-05-09
Decision date: 1994-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.