GSI AUDERA— 510(k) K011135

Substantially Equivalent

Nicolet Biomedical

FDA 510(k) clearance K011135 for GSI AUDERA, Substantially Equivalent on 2001-07-26. Applicant: Nicolet Biomedical.

Clearance details

Applicant: Nicolet Biomedical
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2001-04-13
Decision date: 2001-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Golden, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

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.