K974232
Substantially EquivalentESSENTIAL SHAVER SYSTEM
- Applicant
- Gyrus Ent LLC
- Product code
- EQJ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bartlett, TN, US
Adverse events under product code EQJ
product code EQJ- Malfunction
- 1,552
- Total
- 1,552
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.