STORZ DISPOSABLE BIPOLAR PENCILS— 510(k) K882802

Substantially Equivalent

Storz Instrument Co.

FDA 510(k) clearance K882802 for STORZ DISPOSABLE BIPOLAR PENCILS, Substantially Equivalent on 1988-08-17. Applicant: Storz Instrument Co..

Clearance details

Applicant: Storz Instrument Co.
Product code: Code GXI
Advisory panel: Neurology
Date received: 1988-07-07
Decision date: 1988-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

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.