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FDA 510(k)

StealthStation System with Cranial Software

K-Number: K153660 · 2016-09-14

ApplicantMedtronic Navigation, Inc.
Decision Date2016-09-14
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

StealthStation System with Cranial Software is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-09-14 under approval number K153660. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StealthStation System with Cranial Software?

StealthStation System with Cranial Software is a medical device that received FDA 510(k) clearance on 2016-09-14. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K153660.

When was StealthStation System with Cranial Software approved by the FDA?

StealthStation System with Cranial Software received FDA 510(k) clearance on 2016-09-14, under approval number K153660.

What company makes StealthStation System with Cranial Software?

StealthStation System with Cranial Software is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for StealthStation System with Cranial Software?

The FDA product code for StealthStation System with Cranial Software is HAW.

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Other Devices by Medtronic Navigation, Inc.

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Related Devices (Code: HAW)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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