# K200723: StealthStation FlexENT  (9736242), StealthStation S8 ENT Software (9735762)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jun 26, 2020 after 99 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: 3 generations back to K001284 (2000). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170018: StealthStationTM S8 ENT Software, Medtronic Navigation, Inc. (2017) Summary page 7.
- K153247: Fusion Compact Navigation System, Medtronic Navigation, Inc. (2016) Summary page 7.

## Most influential descendants
- K253395: Stealth AXiS™ ENT clinical application (2026), 0 descendants of its own
- K223734: ENT EM (2023), 0 descendants of its own

## Indications for use
The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or 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 The Medtronic StealthStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or 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.

Source page: https://510kreport.com/device/K200723
Methodology: https://510kreport.com/methodology