Submission Details
| 510(k) Number | K162604 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 19, 2016 |
| Decision Date | December 30, 2016 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Cranial Reducing Tubes
Dec 2016
Decision
102d
Days
Class 2
Risk
About This 510(k) Submission
K162604 is an FDA 510(k) clearance for the Cranial Reducing Tubes, 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 December 30, 2016, 102 days after receiving the submission on September 19, 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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