Cleared Traditional

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

K163412 · Girgis Scope, LLC · Anesthesiology

Jun 2017

Decision

199d

Days

Class 1

Risk

About This 510(k) Submission

K163412 is an FDA 510(k) clearance for the Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL), a Laryngoscope, Rigid (Class I — General Controls, product code CCW), submitted by Girgis Scope, LLC (Monroe Township, US). The FDA issued a Cleared decision on June 22, 2017, 199 days after receiving the submission on December 5, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5540.

Submission Details

510(k) Number	K163412 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2016
Decision Date	June 22, 2017
Days to Decision	199 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF