FDA 510(k)

Navident

K-Number: K210947 · 2022-06-27

Decision Date2022-06-27

Product CodePLV

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Navident is the device name listed in this FDA 510(k) record. The listed applicant is Claronav, Inc.. It received FDA 510(k) clearance on 2022-06-27 under 510(k) number K210947. The device is classified under product code PLV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navident?

Navident is a medical device that received FDA 510(k) clearance on 2022-06-27. The listed applicant is Claronav, Inc.. The 510(k) number is K210947.

When did Navident receive FDA 510(k) clearance?

Navident received FDA 510(k) clearance on 2022-06-27, under 510(k) number K210947.

Who is the listed applicant for Navident?

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 Navident?

The FDA product code for Navident is PLV.

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 K163439NaviENT K161406Navident

Related Devices (Code: PLV)

K252376Yomi S Robotic SystemNeocis, Inc.K251835Yomi Robotic SystemNeocis, Inc.K233563NavidentClaronav, Inc.K231018Yomi Robotic SystemNeocis, Inc.K211466Yomi Robotic System with YomiPlan GoNeocis, Inc.K213392INLIANT Surgical Navigation SystemNavigate Surgical Technologies, 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.