Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sterile Water USP and Sterile 0.9% Normal Saline USP

K-Number: K243001 · 2025-03-06

ApplicantLaboratorios Biogalenic S.A. DE C.V.
Decision Date2025-03-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Sterile Water USP and Sterile 0.9% Normal Saline USP is the device name listed in this FDA 510(k) record. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. It received FDA 510(k) clearance on 2025-03-06 under 510(k) number K243001. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Water USP and Sterile 0.9% Normal Saline USP?

Sterile Water USP and Sterile 0.9% Normal Saline USP is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Laboratorios Biogalenic S.A. DE C.V.. The 510(k) number is K243001.

When did Sterile Water USP and Sterile 0.9% Normal Saline USP receive FDA 510(k) clearance?

Sterile Water USP and Sterile 0.9% Normal Saline USP received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243001.

Who is the listed applicant for Sterile Water USP and Sterile 0.9% Normal Saline USP?

The FDA 510(k) record lists Laboratorios Biogalenic S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Water USP and Sterile 0.9% Normal Saline USP?

The FDA product code for Sterile Water USP and Sterile 0.9% Normal Saline USP is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06339203Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)RECRUITING

Other records listing Laboratorios Biogalenic S.A. DE C.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPK242717Laboratorios Biogalenic Sterile Water for Inhalation, USP

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑