Submission Details
| 510(k) Number | K191597 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 17, 2019 |
| Decision Date | November 01, 2019 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Stealth Autoguide System, Midas Rex Legend Depth Stop System
Nov 2019
Decision
137d
Days
Class 2
Risk
About This 510(k) Submission
K191597 is an FDA 510(k) clearance for the Stealth Autoguide System, Midas Rex Legend Depth Stop 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 November 1, 2019, 137 days after receiving the submission on June 17, 2019. 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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