510(k) K030572— HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE

Substantially Equivalent

Henke Sass Wolf of America, Inc.

Clearance details

Applicant: Henke Sass Wolf of America, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2003-02-24
Decision date: 2003-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flemington, NJ, US

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.