510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K945301Substantially Equivalent

Laryngoscope Cover

Sotiria Mourkidou, M.D., Malibu CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945301 is the FDA 510(k) clearance record for LARYNGOSCOPE COVER, a class I device, cleared for Sotiria Mourkidou, M.D. on under FDA product code CCW (Laryngoscope, Rigid). FDA records list one 510(k) clearance for Sotiria Mourkidou, M.D. As of , FDA records show no recalls naming K945301.

Clearance record

Decision date
Received
(578 days to decision)
Product code
CCW Laryngoscope, Rigid
Regulation
21 CFR 868.5540
Device class
Class I
Review panel
Anesthesiology
Applicant
Sotiria Mourkidou, M.D. 27112 Malibu Cove Colony Dr., Malibu CA
510(k) summary
Statement
Third party review
No

Clearances, product code CCW

Trailing 12 months

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

FDA records show no clearances under product code CCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CCW, 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