Sterile Water USP and Sterile 0.9% Normal Saline USP

FDA 510(k) K243001 · Laboratorios Biogalenic S.A. DE C.V.

Substantially Equivalent

510(k) numberK243001

Submission

Device name
Sterile Water USP and Sterile 0.9% Normal Saline USP
Applicant
Laboratorios Biogalenic S.A. DE C.V.
San Salvador, SV
Received
September 26, 2024
Decision date
March 6, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRO – Dressing, Wound, Drug
Device class
Unclassified

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Questions and answers

When was Sterile Water USP and Sterile 0.9% Normal Saline USP cleared by the FDA?

Sterile Water USP and Sterile 0.9% Normal Saline USP (K243001) received a 510(k) decision of Substantially Equivalent on March 6, 2025, 161 days after the submission was received.

What is the product code of K243001?

The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.