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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2016-12-30 under 510(k) 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. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K162604.

When did Cranial Reducing Tubes receive FDA 510(k) clearance?

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

Who is the listed applicant for Cranial Reducing Tubes?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical PartnersK250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.K250505EZ-FIDUCIALSPhasor Health, LLC

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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