LARYNGOSCOPE COVER— 510(k) K945301

Name: FDA 510(k) clearance K945301
Creator: U.S. Food and Drug Administration
Published: 1996-05-31

Substantially Equivalent

Sotiria Mourkidou, M.D.

FDA 510(k) clearance K945301 for LARYNGOSCOPE COVER, Substantially Equivalent on 1996-05-31. Applicant: Sotiria Mourkidou, M.D.. Device class: 1.

Clearance details

Applicant: Sotiria Mourkidou, M.D.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1994-10-31
Decision date: 1996-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malibu, CA, US

Download summary PDF View on FDA.gov ↗

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K140951 — YEESCOPE LARYNGOSCOPES2014-11-10
K121378 — AIRTRAQ SP AIRTRAQ AVANT2012-06-21
K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET2007-02-09

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.