CLARUS SPINEPEN MODEL 2126— 510(k) K955598

Substantially Equivalent

Clarus Medical Systems, Inc.

FDA 510(k) clearance K955598 for CLARUS SPINEPEN MODEL 2126, Substantially Equivalent on 1996-02-06. Applicant: Clarus Medical Systems, Inc..

Clearance details

Applicant: Clarus Medical Systems, Inc.
Product code: Code GWG
Advisory panel: Neurology
Date received: 1995-12-08
Decision date: 1996-02-06
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.