SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216— 510(k) K061115

Substantially Equivalent

Gvs Spa

FDA 510(k) clearance K061115 for SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216, Substantially Equivalent on 2006-06-30. Applicant: Gvs Spa.

Clearance details

Applicant: Gvs Spa
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2006-04-21
Decision date: 2006-06-30
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Manchester, MI, 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.