AUDIT— 510(k) K822335

Substantially Equivalent

Axonics, Inc.

FDA 510(k) clearance K822335 for AUDIT, Substantially Equivalent on 1983-02-07. Applicant: Axonics, Inc..

Clearance details

Applicant: Axonics, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1982-08-04
Decision date: 1983-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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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.