ENK FIBEROPTIC ATOMIZER SET— 510(k) K031966

Unknown

Cook, Inc.

FDA 510(k) clearance K031966 for ENK FIBEROPTIC ATOMIZER SET, Unknown on 2003-10-16. Applicant: Cook, Inc..

Clearance details

Applicant: Cook, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2003-06-26
Decision date: 2003-10-16
Decision: Unknown
Clearance type: Traditional
Location: Bloomington, IN, US

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.