GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE— 510(k) K994166

Substantially Equivalent

Gyrus Medical , Ltd.

FDA 510(k) clearance K994166 for GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE ELECTRODE, Substantially Equivalent on 1999-12-27. Applicant: Gyrus Medical , Ltd..

Clearance details

Applicant: Gyrus Medical , Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 1999-12-09
Decision date: 1999-12-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Cardiff, Wales, GB

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Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.