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510(k) K002255

LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) by Wolfe Tory Medical, Inc. — Product Code CCT

K002255 is an FDA 510(k) premarket notification submitted by Wolfe Tory Medical, Inc. for the device "LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)". The FDA issued a decision of Substantially Equivalent on September 18, 2000. The device falls under product code CCT (Applicator (Laryngo-Tracheal), Topical Anesthesia), a Class II device regulated under 21 CFR 868.5170. Wolfe Tory Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2000
Date Received
July 25, 2000
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 Wolfe Tory Medical, Inc.

  • K021044 — MADETT (September 11, 2002)
  • K990556 — ESOPHAGEAL INTUBATION DETECTOR (March 26, 1999)
  • K945745 — ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER) (December 7, 1994)
  • K942628 — ESOPHAGEAL INTUBATION DETECTOR BULB (August 18, 1994)

Other clearances for product code CCT

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