GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML— 510(k) K031419

Substantially Equivalent

Laboratorios Grifols, S.A.

FDA 510(k) clearance K031419 for GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML, Substantially Equivalent on 2003-11-24. Applicant: Laboratorios Grifols, S.A..

Clearance details

Applicant: Laboratorios Grifols, S.A.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 2003-05-05
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parets Del Valles, Barcelona, ES

Download summary PDF View on FDA.gov ↗

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.