510(k) · Cleared
ClearedStryker Essx Microdebrider System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Ireland Ltd., Instruments Division · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Aug 26, 2008 as substantially equivalent to K011381 (Stryker Instruments, 2001) and 2 other predicates after a 244-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Aug 26, 2008
- Review
- 244 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002224 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002224 | XPS 3000 System | Medtronic Xomed | 2000 | — |
| −1 | K041523 | XPS 3000 System | Medtronic Xomed, Inc. | 2004 | — |
| 0 (this device) | K073633 | Stryker Essx Microdebrider System | Stryker Ireland Ltd., Instruments Division | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ERL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011381 | Hummer IV Microdebrider SystemSummary page 1…Ear, Nose and Throat Bur (EQJ) Blade, Saw, General and Plastic Surgery, Surgical (GFA) Equivalent to: K011381 Stryker Hummer IV MicroDebrider K041523 Medtronic XPS 3000… | 2001 |
| * | K041523 | XPS 3000 SystemSummary page 1…Blade, Saw, General and Plastic Surgery, Surgical (GFA) Equivalent to: K011381 Stryker Hummer IV MicroDebrider K041523 Medtronic XPS 3000 K020694 Gyrus Diego Powered Dissector and Drill Device Description:… | 2004 |
| * | K020594 | Diego Powered Dissector and Drill System 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”. | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K011381.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073633: Stryker Essx Microdebrider System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073633
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026