HEMODIALYSIS SYSTEM AND ACCESSORY— 510(k) K902426

Substantially Equivalent

Gainor Medical Europe, Ltd.

FDA 510(k) clearance K902426 for HEMODIALYSIS SYSTEM AND ACCESSORY, Substantially Equivalent on 1990-11-20. Applicant: Gainor Medical Europe, Ltd..

Clearance details

Applicant: Gainor Medical Europe, Ltd.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1990-05-31
Decision date: 1990-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcdonough, GA, US

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.