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510(k) K240114

UltraEzAir® (UEA1A) by Dualams, Inc., Dba Airkor — Product Code CCT

K240114 is an FDA 510(k) premarket notification submitted by Dualams, Inc., Dba Airkor for the device "UltraEzAir® (UEA1A)". The FDA issued a decision of Substantially Equivalent on October 16, 2024. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2024
Date Received
January 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator (Laryngo-Tracheal), Topical Anesthesia
Device Class
Class II
Regulation Number
868.5170
Review Panel
AN
Submission Type

Other clearances for product code CCT

  • K172956 — Medicant Mucosal Atomizer (April 6, 2018)
  • K153470 — MADgic Laryngo-Tracheal Mucosal Atomization Device (August 19, 2016)
  • K093584 — EZ-MISTER (March 4, 2011)
  • K070596 — TOPICAL APPLICATOR (June 21, 2007)
  • K002255 — LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (September 18, 2000)
  • K894755 — ASTRA DISPOSABLE SPRAY CANNULA (January 12, 1990)
  • K810059 — ENDO-MED TUBE FOR ENDOTRACHEAL MED (February 26, 1981)
  • K760759 — ANESTHESIA KIT (December 9, 1976)
  • K760877 — MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT (December 9, 1976)

FDA data resources