GRI-BAG, GRI-BAG AP— 510(k) K033916

Name: FDA 510(k) clearance K033916
Creator: U.S. Food and Drug Administration
Published: 2003-12-30

Substantially Equivalent

Laboratorios Grifols, S.A.

FDA 510(k) clearance K033916 for GRI-BAG, GRI-BAG AP, Substantially Equivalent on 2003-12-30. Applicant: Laboratorios Grifols, S.A.. Device class: 2.

Clearance details

Applicant: Laboratorios Grifols, S.A.
Product code: Code KPE
Device class: Class 2
Regulation: 21 CFR 880.5025
Advisory panel: General Hospital
Date received: 2003-12-18
Decision date: 2003-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parets Del Valles, Barcelona, ES

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.