Nitinol Thermocouple (TCN) Electrode— 510(k) K183177
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K183177 for Nitinol Thermocouple (TCN) Electrode, Substantially Equivalent on 2019-03-08. Applicant: Boston Scientific Corporation.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code GXI
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Valencia, CA, 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.