SET GRI-FILL 3.0— 510(k) K093182

Substantially Equivalent

Laboratorios Grifols, S.A.

FDA 510(k) clearance K093182 for SET GRI-FILL 3.0, Substantially Equivalent on 2010-01-27. Applicant: Laboratorios Grifols, S.A..

Clearance details

Applicant: Laboratorios Grifols, S.A.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2009-10-08
Decision date: 2010-01-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Parets Del Valles, Barcelona, ES

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.