Cleared Traditional

Medicant Mucosal Atomizer

K172956 · Medica Holdings, LLC · Anesthesiology

Apr 2018

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K172956 is an FDA 510(k) clearance for the Medicant Mucosal Atomizer, a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by Medica Holdings, LLC (Lake Oswego, US). The FDA issued a Cleared decision on April 6, 2018, 192 days after receiving the submission on September 26, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.

Submission Details

510(k) Number	K172956 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2017
Decision Date	April 06, 2018
Days to Decision	192 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF