GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE— 510(k) K001270

Substantially Equivalent

Gyrus Medical , Ltd.

FDA 510(k) clearance K001270 for GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE, Substantially Equivalent on 2000-04-28. Applicant: Gyrus Medical , Ltd..

Clearance details

Applicant: Gyrus Medical , Ltd.
Product code: Code FJL
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-20
Decision date: 2000-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Cardiff, Wales, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code FJL

product code FJL

Death: 2
Total: 2

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.