STELTHSTATION WIRELESS SURGEON MOUSE— 510(k) K051029
Substantially EquivalentMedtronic Surgical Navigation
FDA 510(k) clearance K051029 for STELTHSTATION WIRELESS SURGEON MOUSE, Substantially Equivalent on 2005-06-08. Applicant: Medtronic Surgical Navigation.
Clearance details
- Applicant
- Medtronic Surgical Navigation
- Product code
- Code HAW
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Louisville, CO, 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.