Cleared Traditional

Sterile Water USP and Sterile 0.9% Normal Saline USP (K243001) - FDA 510(k) Clearance

K243001 · Laboratorios Biogalenic S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
161d
Days
-
Risk

K243001 is an FDA 510(k) clearance for the Sterile Water USP and Sterile 0.9% Normal Saline USP. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Laboratorios Biogalenic S.A. DE C.V. (San Salvador, SV). The FDA issued a Cleared decision on March 6, 2025 after a review of 161 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Laboratorios Biogalenic S.A. DE C.V. devices

Submission Details

510(k) Number K243001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2024
Decision Date March 06, 2025
Days to Decision 161 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 115d · This submission: 161d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Liberty Management Group , Ltd.
Manoj Zacharias

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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