Cleared Traditional

K163412 - Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

K163412 is an FDA 510(k) clearance for Girgis Scope Video 200 Double Bladed La..., manufactured by Girgis Scope, LLC. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K163412 · Girgis Scope, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K163412

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Smith Associates
E. J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CCW Laryngoscope, Rigid

All 32
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