510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060231Substantially Equivalent

Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock

Elcam Medical A.C.A.L., Mp. Merom Hagalil, IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060231 is the FDA 510(k) clearance record for CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK, a class II device, cleared for Elcam Medical Acal on under FDA product code FMG (Stopcock, I.V. Set). FDA records list 16 510(k) clearances for Elcam Medical Acal, from to . As of , FDA records show 20 recalls naming K060231.

Clearance record

Decision date
Received
(73 days to decision)
Product code
FMG Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Elcam Medical Acal Kibbutz Bar-Am, Mp. Merom Hagalil, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMG

Trailing 12 months

FDA records hold no clearances under product code FMG in the trailing twelve months.

FDA records show no clearances under product code FMG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260