Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4— 510(k) K221087
Substantially EquivalentMedtronic Navigation, Inc.
FDA 510(k) clearance K221087 for Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4, Substantially Equivalent on 2022-06-10. Applicant: Medtronic Navigation, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Navigation, Inc.
- 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, Inc.
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 K221087
K-number listed on FDA's recall record- Z-1630-2023 — StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
- Z-1666-2023 — StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221087.
Data sourced from openFDA. This site is unofficial and independent of the FDA.