GYRUS ENT NERVE STIMULATOR— 510(k) K021595
Substantially EquivalentGyrus Ent LLC
FDA 510(k) clearance K021595 for GYRUS ENT NERVE STIMULATOR, Substantially Equivalent on 2002-10-24. Applicant: Gyrus Ent LLC. Device class: 2.
Clearance details
- Applicant
- Gyrus Ent LLC
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
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Adverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
Source: openFDA MAUDE database, through . 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.