Cleared Traditional

K243001 - Sterile Water USP and Sterile 0.9% Norm...

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

FDA 510(k) Submission Details - K243001

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.

FRO Device Classification - Class 0,

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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