Laryngo-Tracheal Mucosal Atomization Device (Madgic)

FDA 510(k) K002255 · Wolfe Tory Medical, Inc.

Substantially Equivalent

510(k) numberK002255

Submission

Device name
Laryngo-Tracheal Mucosal Atomization Device (Madgic)
Applicant
Wolfe Tory Medical, Inc.
Salt Lake City, UT, US
Received
July 25, 2000
Decision date
September 18, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCT – Applicator (Laryngo-Tracheal), Topical Anesthesia
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5170
Specialty
Anesthesiology

Other 510(k)s with product code CCT

510(k)DeviceApplicantDecision
K240114UltraEzAir® (UEA1A)CCT · Traditional Dualams, Inc., Dba Airkor10/16/2024SE
K172956Medicant Mucosal AtomizerCCT · Traditional Medica Holdings, LLC04/06/2018SE
K153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceCCT · Traditional Teleflex Medical08/19/2016SE
K093584Ez-MisterCCT · Traditional N.M. Beale Co., Inc.03/04/2011SE
K070596Topical ApplicatorCCT · Traditional Sharn, Inc.06/21/2007SE
K894755Astra Disposable Spray CannulaCCT · Traditional Astra Pharmaceutical Products, Inc.01/12/1990SE
K810059Endo-Med Tube for Endotracheal MedCCT · Traditional Ackrad Laboratories02/26/1981SE
K760877Monoject Laryngotracheal Anesthesia KitCCT · Traditional Sherwood Medical Industries12/09/1976SE
K760759Anesthesia KitCCT · Traditional Sherwood Medical Industries12/09/1976SE

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K990556Esophageal Intubation DetectorBTR · Traditional 03/26/1999SE
K945745Esophageal Intubation Detector Adapter - (Eid-Adapter)BTR · Traditional 12/07/1994SE
K942628Esophageal Intubation Detector BulbBTR · Traditional 08/18/1994SE

Questions and answers

When was Laryngo-Tracheal Mucosal Atomization Device (Madgic) cleared by the FDA?

Laryngo-Tracheal Mucosal Atomization Device (Madgic) (K002255) received a 510(k) decision of Substantially Equivalent on September 18, 2000, 55 days after the submission was received.

What is the product code of K002255?

The FDA product code is CCT – Applicator (Laryngo-Tracheal), Topical Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5170.