# K073633: Stryker Essx Microdebrider System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Ireland Ltd., Instruments Division
- Decided: Aug 26, 2008 after 244 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 K002224 (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)
- K011381: Hummer IV Microdebrider System, Stryker Instruments (2001) Summary page 1.
- K041523: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 1.
- K020594: Diego Powered Dissector and Drill System, Gyrus Ent LLC (2002). Our reading of the summary gave K020694, FDA’s number for QAB2A Igm Elisa Kit (Cheshire Diagnostics, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Gyrus Diego Powered Dissector and Drill”.

## Indications for use
The ESSx Microdebrider System is intended for the cutting and removal of soft and osseous tissue in general ENT encompassing the areas of Sinus, Nasopharyngeal /Laryngeal and Head and Neck procedures, such as the following: Sinus: - ethmoidectomy/sphenoethmoidectomy - polypectomy - septoplasty - antrostomy - endoscopic DCR - frontal sinus drill-out - frontal sinus trephination - septal spurs removal - trans-sphenoidal procedures Nasopharyngeal/laryngeal: - adenoidectomy - laryngeal lesion debulldng - laryngeal polypectomy - tracheal procedures - tonsillectomy Head & Neck: - soft tissue shaving - rhinoplasty - removal of fatty tissue in the maxillary and mandibular regions of the face

Source page: https://510kreport.com/device/K073633
Methodology: https://510kreport.com/methodology