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

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.

Clearance details

Applicant: Girgis Scope, LLC
Product code: Code CCW
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 ↗

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.