# K163439: NaviENT

- Pathway: 510(k) (Traditional)
- Applicant: Claronav, Inc.
- Decided: Sep 1, 2017 after 267 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983831 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122096: Karl Storz Navigationpanel Unit (Npu) System, KARL STORZ Endoscopy-America, Inc. (2012) Summary page 4.

## Most influential descendants
- K243053: Navient Image Guided Navigation System (ENT) (955-NC-NC) (2025), 0 descendants of its own

## Indications for use
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient’s head. The device is intended for use by a qualified ENT surgeon (otolaryngologist). NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.

Source page: https://510kreport.com/device/K163439
Methodology: https://510kreport.com/methodology