Submission Details
| 510(k) Number | K133444 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2013 |
| Decision Date | July 25, 2014 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
Jul 2014
Decision
255d
Days
Class 2
Risk
About This 510(k) Submission
K133444 is an FDA 510(k) clearance for the STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION 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 July 25, 2014, 255 days after receiving the submission on November 12, 2013. 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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