NEEDLE, ASPIRATION & INJECTION, DISPOSABLE— 510(k) K902422
Substantially EquivalentGainor Medical Europe, Ltd.
FDA 510(k) clearance K902422 for NEEDLE, ASPIRATION & INJECTION, DISPOSABLE, Substantially Equivalent on 1991-06-06. Applicant: Gainor Medical Europe, Ltd..
Clearance details
- Applicant
- Gainor Medical Europe, Ltd.
- Product code
- Code FMI
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcdonough, GA, US
Adverse events under product code FMI
product code FMI- Death
- 28
- Injury
- 1,517
- Malfunction
- 23,981
- Other
- 18
- Total
- 25,544
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.