FDA 510(k)

NaviENT

K-Number: K163439 · 2017-09-01

Decision Date2017-09-01

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NaviENT is the device name listed in this FDA 510(k) record. The listed applicant is Claronav, Inc.. It received FDA 510(k) clearance on 2017-09-01 under 510(k) number K163439. 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 NaviENT?

NaviENT is a medical device that received FDA 510(k) clearance on 2017-09-01. The listed applicant is Claronav, Inc.. The 510(k) number is K163439.

When did NaviENT receive FDA 510(k) clearance?

NaviENT received FDA 510(k) clearance on 2017-09-01, under 510(k) number K163439.

Who is the listed applicant for NaviENT?

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

What is the FDA product code for NaviENT?

The FDA product code for NaviENT is HAW.

Other records listing Claronav, Inc. as applicant

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.

K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)K241327Navient Image Guide Navigation System (955-NC-NC), Cranial K233563Navident K210947Navident K161406Navident

Related Devices (Code: HAW)

K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB K253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners K250893Ball Joint Guide Array (66295)Bayer Medical Care, Inc.

Official Source

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