Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)— 510(k) K163412

Name: FDA 510(k) clearance K163412
Creator: U.S. Food and Drug Administration
Published: 2017-06-22

Substantially Equivalent

Girgis Scope, LLC

FDA 510(k) clearance K163412 for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL), Substantially Equivalent on 2017-06-22. Applicant: Girgis Scope, LLC. Device class: 1.

Clearance details

Applicant: Girgis Scope, LLC
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 2016-12-05
Decision date: 2017-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe Township, NJ, US

Download summary PDF View on FDA.gov ↗

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K191602 — APA Oxy Blade2019-08-02
K140951 — YEESCOPE LARYNGOSCOPES2014-11-10
K121378 — AIRTRAQ SP AIRTRAQ AVANT2012-06-21
K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET2007-02-09
K062523 — TRU-MR LARYNGOSCOPE SET2006-11-17

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.