I.V. ADMINISTRATION SET— 510(k) K926448

Substantially Equivalent

Gainor Medical Europe, Ltd.

FDA 510(k) clearance K926448 for I.V. ADMINISTRATION SET, Substantially Equivalent on 1994-05-02. Applicant: Gainor Medical Europe, Ltd..

Clearance details

Applicant: Gainor Medical Europe, Ltd.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1992-12-23
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcdonough, GA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.