# K223734: ENT EM

- Pathway: 510(k) (Traditional)
- Applicant: Brainlab AG
- Decided: Apr 27, 2023 after 135 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 4.

## Indications for use
ENT EM is intended as an image-guided planning and navigation system to enable ENT procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-Ray, MR, MRA and ultrasound) of the anatomy, such as: * Intranasal structures and Paranasal Sinus Surgery o Functional endoscopic sinus surgery (FESS) o Intranasal structures and paranasal sinus surgery, including revision and distorted anatomy * Anterior skull base procedures

Source page: https://510kreport.com/device/K223734
Methodology: https://510kreport.com/methodology