RADIONICS POLE NEEDLES— 510(k) K021942
Substantially EquivalentRadionics, A Division of Tyco Healthcare Group LP
FDA 510(k) clearance K021942 for RADIONICS POLE NEEDLES, Substantially Equivalent on 2002-09-11. Applicant: Radionics, A Division of Tyco Healthcare Group LP.
Clearance details
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Product code
- Code GXI
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
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.