Submission Details
| 510(k) Number | K190672 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 15, 2019 |
| Decision Date | July 31, 2019 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
Jul 2019
Decision
138d
Days
Class 2
Risk
About This 510(k) Submission
K190672 is an FDA 510(k) clearance for the StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Medtronic Navigation, Inc. (Louisville, US). The FDA issued a Cleared decision on July 31, 2019, 138 days after receiving the submission on March 15, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.
Device Classification
| Product Code | HAW — Neurological Stereotaxic Instrument |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.4560 |
Manufacturer
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