Submission Details
| 510(k) Number | K162655 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 23, 2016 |
| Decision Date | April 21, 2017 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
StealthConnect Remote Viewing, Planning and Collaboration System
Apr 2017
Decision
210d
Days
Class 2
Risk
About This 510(k) Submission
K162655 is an FDA 510(k) clearance for the StealthConnect Remote Viewing, Planning and Collaboration System, 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 April 21, 2017, 210 days after receiving the submission on September 23, 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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