Cleared Traditional

LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)

K002255 · Wolfe Tory Medical, Inc. · Anesthesiology

Sep 2000

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K002255 is an FDA 510(k) clearance for the LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC), a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by Wolfe Tory Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 18, 2000, 55 days after receiving the submission on July 25, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.

Submission Details

510(k) Number	K002255 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2000
Decision Date	September 18, 2000
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF