RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE— 510(k) K032054
Substantially EquivalentRadionics, A Division of Tyco Healthcare Group LP
FDA 510(k) clearance K032054 for RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE, Substantially Equivalent on 2003-09-15. Applicant: Radionics, A Division of Tyco Healthcare Group LP.
Clearance details
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Product code
- Code HAW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
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.