Cleared Traditional

K163412 - Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) (FDA 510(k) Clearance)

Class I Anesthesiology device.

K163412 · Girgis Scope, LLC · Anesthesiology device
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Jun 2017
Decision
199d
Days
Class 1
Risk

K163412 is an FDA 510(k) clearance for the Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL). Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Girgis Scope, LLC (Monroe Township, US). The FDA issued a Cleared decision on June 22, 2017 after a review of 199 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Girgis Scope, LLC devices

Submission Details

510(k) Number K163412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 139d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.