GYRUS ENT NERVE STIMULATOR— 510(k) K021595

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K021595 for GYRUS ENT NERVE STIMULATOR, Substantially Equivalent on 2002-10-24. Applicant: Gyrus Ent LLC.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2002-05-15
Decision date: 2002-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.