MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002— 510(k) K041852

Name: FDA 510(k) clearance K041852
Creator: U.S. Food and Drug Administration
Published: 2004-11-15

Substantially Equivalent

Minrad, Inc.

FDA 510(k) clearance K041852 for MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002, Substantially Equivalent on 2004-11-15. Applicant: Minrad, Inc.. Device class: 1.

Clearance details

Applicant: Minrad, Inc.
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 2004-07-08
Decision date: 2004-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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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.