DIRECT VIEW 2001 FIBERLIGHT— 510(k) K945901

Name: FDA 510(k) clearance K945901
Creator: U.S. Food and Drug Administration
Published: 1994-12-27

Substantially Equivalent

Mercury Medical

FDA 510(k) clearance K945901 for DIRECT VIEW 2001 FIBERLIGHT, Substantially Equivalent on 1994-12-27. Applicant: Mercury Medical. Device class: 1.

Clearance details

Applicant: Mercury Medical
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1994-12-02
Decision date: 1994-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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.