Sterile Water USP and Sterile 0.9% Normal Saline USP— 510(k) K243001

Substantially Equivalent

Laboratorios Biogalenic S.A. DE C.V.

FDA 510(k) clearance K243001 for Sterile Water USP and Sterile 0.9% Normal Saline USP, Substantially Equivalent on 2025-03-06. Applicant: Laboratorios Biogalenic S.A. DE C.V..

Clearance details

Applicant: Laboratorios Biogalenic S.A. DE C.V.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2024-09-26
Decision date: 2025-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Salvador, SV

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.