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FDA 510(k)

Navient Image Guided Navigation System (ENT) (955-NC-NC)

K-Number: K243053 · 2025-06-20

ApplicantClaronav
Decision Date2025-06-20
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Navient Image Guided Navigation System (ENT) (955-NC-NC) is the device name listed in this FDA 510(k) record. The listed applicant is Claronav. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K243053. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navient Image Guided Navigation System (ENT) (955-NC-NC)?

Navient Image Guided Navigation System (ENT) (955-NC-NC) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Claronav. The 510(k) number is K243053.

When did Navient Image Guided Navigation System (ENT) (955-NC-NC) receive FDA 510(k) clearance?

Navient Image Guided Navigation System (ENT) (955-NC-NC) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K243053.

Who is the listed applicant for Navient Image Guided Navigation System (ENT) (955-NC-NC)?

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

What is the FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC)?

The FDA product code for Navient Image Guided Navigation System (ENT) (955-NC-NC) is PGW.

Related Clinical Trials

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.

NCT05132283Urologic Lymphadenectomy in AMIGORECRUITING

Other records listing Claronav 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.

K241327Navient Image Guide Navigation System (955-NC-NC), CranialK233563NavidentK210947NavidentK163439NaviENTK161406Navident

Related Devices (Code: PGW)

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.

K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbHK253395Stealth AXiS™ ENT clinical applicationMedtronic Navigation, Inc.K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.K223734ENT EMBrainlab AGK221037TruDi Shaver BladeAcclarent, Inc.K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitStryker Corporation

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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