Cleared Traditional

Navient Image Guide Navigation System (955-NC-NC), Cranial

K241327 · Claronav · Neurology

Feb 2025

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K241327 is an FDA 510(k) clearance for the Navient Image Guide Navigation System (955-NC-NC), Cranial, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Claronav (Toronto, CA). The FDA issued a Cleared decision on February 5, 2025, 271 days after receiving the submission on May 10, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K241327 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2024
Decision Date	February 05, 2025
Days to Decision	271 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF