# K243053: Navient Image Guided Navigation System (ENT) (955-NC-NC)

- Pathway: 510(k) (Traditional)
- Applicant: Claronav
- Decided: Jun 20, 2025 after 266 days
- Product code: PGW (Ear, Nose, And Throat 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: 4 generations back to K983831 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163439: NaviENT, Claronav, Inc. (2017) Summary page 5.

## Indications for use
Navient is a computerized surgical navigation system intended as an aid for precisely locating anatomical structures. The Navient system 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 a CT, MR-based anatomy model. Indications: Example procedures include but are not limited to: ENT Procedures: • Transsphenoidal procedures • Maxillary antrostomies • Ethmoidectomies • sphenoidotomies • Sphenoid explorations • Turbinate resections • Frontal sinusotomies • Intranasal procedures • Intranasal tumor resections • All ENT related skull base surgery

Source page: https://510kreport.com/device/K243053
Methodology: https://510kreport.com/methodology