Submission Details
| 510(k) Number | K150216 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 30, 2015 |
| Decision Date | June 11, 2015 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Synergy Cranial
Jun 2015
Decision
132d
Days
Class 2
Risk
About This 510(k) Submission
K150216 is an FDA 510(k) clearance for the Synergy Cranial, 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 June 11, 2015, 132 days after receiving the submission on January 30, 2015. 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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