StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1— 510(k) K190672
Substantially EquivalentMedtronic Navigation, Inc.
FDA 510(k) clearance K190672 for StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1, Substantially Equivalent on 2019-07-31. 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 K190672
K-number listed on FDA's recall record- Z-1666-2023 — StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
- Z-0383-2022 — Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763, and StealthStation Cranial, Model: 9735585
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190672.
Data sourced from openFDA. This site is unofficial and independent of the FDA.