Submission Details
| 510(k) Number | K162309 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 2016 |
| Decision Date | March 31, 2017 |
| Days to Decision | 226 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
StealthStation S8 System Platforms and StealthStation Cranial Software
Mar 2017
Decision
226d
Days
Class 2
Risk
About This 510(k) Submission
K162309 is an FDA 510(k) clearance for the StealthStation S8 System Platforms and StealthStation Cranial Software, 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 March 31, 2017, 226 days after receiving the submission on August 17, 2016. 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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