510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243001Substantially Equivalent

Sterile Water USP and Sterile 0.9% Normal Saline USP

Laboratorios Biogalenic, S.A. de C.V., San Salvador, SV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243001 is the FDA 510(k) clearance record for Sterile Water USP and Sterile 0.9% Normal Saline USP, cleared for Laboratorios Biogalenic S.A. DE C.V. on under FDA product code FRO (Dressing, Wound, Drug). FDA records list 3 510(k) clearances for Laboratorios Biogalenic S.A. DE C.V., from to . As of , FDA records show no recalls naming K243001.

Clearance record

Decision date
Received
(161 days to decision)
Product code
FRO Dressing, Wound, Drug
Device class
Unclassified
Review panel
Unknown
Applicant
Laboratorios Biogalenic S.A. DE C.V. Calle Claper, Blvd. Del Ejercito Nacional Km 5.5,, San Salvador, SV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FRO

Trailing 12 months
19 clearances under product code FRO in the twelve months to October 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FRO, trailing twelve months
MonthClearances
November 20251
December 20251
January 20264
February 20261
March 20263
April 20261
May 20261
June 20263
July 20260
August 20262
September 20262
October 20260