PLASMAKINETIC ENDOUROLOGY SYSTEM— 510(k) K003569

Substantially Equivalent

Gyrus Medical , Ltd.

FDA 510(k) clearance K003569 for PLASMAKINETIC ENDOUROLOGY SYSTEM, Substantially Equivalent on 2000-12-19. Applicant: Gyrus Medical , Ltd..

Clearance details

Applicant: Gyrus Medical , Ltd.
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2000-11-20
Decision date: 2000-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Cardiff, Wales, GB

Download summary PDF View on FDA.gov ↗

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.