StealthStation S8 Cranial v2.0— 510(k) K212397
Substantially EquivalentMedtronic Navigation
FDA 510(k) clearance K212397 for StealthStation S8 Cranial v2.0, Substantially Equivalent on 2021-12-22. Applicant: Medtronic Navigation. Device class: 2.
Clearance details
- Applicant
- Medtronic Navigation
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Louisville, CO, US
Recent devices under product code HAW
view allMore clearances from Medtronic Navigation
view allAdverse 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 →
Recalls naming K212397
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212397.
Data sourced from openFDA. This site is unofficial and independent of the FDA.