# K253395: Stealth AXiS™ ENT clinical application

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 16, 2026 after 167 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 K001284 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200723: StealthStation FlexENT  (9736242), StealthStation S8 ENT Software (9735762), Medtronic Navigation, Inc. (2020) Summary page 5.

## Indications for use
The Stealth AXiST Surgical System, with the Stealth AXiST ENT clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and percutaneous ENT procedures. Their use 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. This can include, but is not limited to, the following procedures: * Functional endoscopic sinus surgery (FESS) * Endoscopic skull base procedures * Lateral skull base procedures

Source page: https://510kreport.com/device/K253395
Methodology: https://510kreport.com/methodology