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FDA 510(k)

Cranial Reducing Tubes

K-Number: K162604 · 2016-12-30

ApplicantMedtronic Navigation, Inc.
Decision Date2016-12-30
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Cranial Reducing Tubes is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-12-30 under approval number K162604. 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 Cranial Reducing Tubes?

Cranial Reducing Tubes is a medical device that received FDA 510(k) clearance on 2016-12-30. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K162604.

When was Cranial Reducing Tubes approved by the FDA?

Cranial Reducing Tubes received FDA 510(k) clearance on 2016-12-30, under approval number K162604.

What company makes Cranial Reducing Tubes?

Cranial Reducing Tubes is manufactured by Medtronic Navigation, Inc..

What is the FDA product code for Cranial Reducing Tubes?

The FDA product code for Cranial Reducing Tubes is HAW.

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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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