CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A— 510(k) K852827

Substantially Equivalent

Cordis Corp.

FDA 510(k) clearance K852827 for CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A, Substantially Equivalent on 1985-08-14. Applicant: Cordis Corp..

Clearance details

Applicant: Cordis Corp.
Product code: Code GZB
Advisory panel: Neurology
Date received: 1985-07-02
Decision date: 1985-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.