BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK— 510(k) K061307
Substantially EquivalentAaron Medical Industries
FDA 510(k) clearance K061307 for BOVIE INAFLASH SUTURE REMOVER HANDLE,CHARGER,HANDLE AND CHARGER,KIT,BATTERY PACK, Substantially Equivalent on 2006-07-18. Applicant: Aaron Medical Industries.
Clearance details
- Applicant
- Aaron Medical Industries
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Petersburg, FL, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.