# K080052: Stryker Essx with Navigation Mount

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Oct 2, 2008 after 268 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020594 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011381: Hummer IV Microdebrider System, Stryker Instruments (2001)
- K030343: Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface, Gyrus Ent LLC (2003) Summary page 1.
- K041523: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 1.

## Indications for use
The Stryker ESSx with Navigation Mount is to be utilized for Functional Endoscopic Sinus Surgery (FESS) for the incision of soft and osseous tissue in the sinus cavities, open plastic, reconstructive and aesthetic surgery of the Head and Neck. When used in conjunction with the Stryker Navigation/Tracker System, the device will enhance the surgeon's ability to localize anatomical landmarks (intraoperatively).

Source page: https://510kreport.com/device/K080052
Methodology: https://510kreport.com/methodology