Cleared Traditional

Cadwell Sierra Summit, Cadwell Sierra Ascent

K162383 · Cadwell Industries, Inc. · Neurology

Mar 2017

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K162383 is an FDA 510(k) clearance for the Cadwell Sierra Summit, Cadwell Sierra Ascent, a Electromyograph, Diagnostic (Class II — Special Controls, product code IKN), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on March 1, 2017, 188 days after receiving the submission on August 25, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1375.

Submission Details

510(k) Number	K162383 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2016
Decision Date	March 01, 2017
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF