Cleared Traditional

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

K243053 · Claronav · Ear, Nose, Throat

Jun 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K243053 is an FDA 510(k) clearance for the Navient Image Guided Navigation System (ENT) (955-NC-NC), a Ear, Nose, And Throat Stereotaxic Instrument (Class II — Special Controls, product code PGW), submitted by Claronav (Toronto, CA). The FDA issued a Cleared decision on June 20, 2025, 266 days after receiving the submission on September 27, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K243053 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2024
Decision Date	June 20, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	Intended As An Aid For Precisely Locating A Surgical Instrument Within Anatomical Structures In Either Open Or Percutaneous Procedures For Any Medical Condition In Which A Reference To A Rigid Anatomical Structure In The Field Of Ent Surgery Can Be Identified Relative To A Ct- Or Mr-based Model Or Digitized Landmarks Of The Anatomy.