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510(k) K172956

Medicant Mucosal Atomizer by Medica Holdings, LLC — Product Code CCT

K172956 is an FDA 510(k) premarket notification submitted by Medica Holdings, LLC for the device "Medicant Mucosal Atomizer". The FDA issued a decision of Substantially Equivalent on April 6, 2018. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Medica Holdings, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2018
Date Received
September 26, 2017
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 by Medica Holdings, LLC

  • K163091 — VibraPEP (February 21, 2017)
  • K153441 — VibraPEP (March 25, 2016)

Other clearances for product code CCT

  • K240114 — UltraEzAir® (UEA1A) (October 16, 2024)
  • 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