510(k) · Cleared
ClearedStryker Hummer II Microdebrider System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Oct 1, 1997 after an 83-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Oct 1, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK972584 Stryker Hummer II Microdebrider SystemStryker Endoscopy · 1997
- Descendant · cites it directly · 9 of its ownK984521 Riwo Drive System 2302 with Generator, Small Motor Handles…Richard Wolf Medical Instruments Corp. · 1999
- Descendant · 2 generations on · 8 of its ownK030082 Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911…Richard Wolf Medical Instruments Corp. · 2003
- Descendant · 3 generations on · 6 of its ownK041610 Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004
- Descendant · 4 generations on · 2 of its ownK192499 Cyber BladeSIDAM S.r.l. · 2020
- Descendant · 4 generations on · 1 of its ownK213597 MultiCut SoloAsclepion Laser Technologies GmbH · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K984521Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351Richard Wolf Medical Instruments Corp. · 1999 · cites it directly9descendants
- K030082Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851Richard Wolf Medical Instruments Corp. · 2003 · 2 generations on8descendants
- K041610Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207Richard Wolf Medical Instruments Corp. · 2004 · 3 generations on6descendants
- K192499Cyber BladeSIDAM S.r.l. · 2020 · 4 generations on2descendants
- K213597MultiCut SoloAsclepion Laser Technologies GmbH · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972584 | Stryker Hummer II Microdebrider System | Stryker Endoscopy | 1997 | — |
| +1 | K984521 | Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 | Richard Wolf Medical Instruments Corp. | 1999 | — |
| +2 | K030082 | Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +3 | K041610 | Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 | Richard Wolf Medical Instruments Corp. | 2004 | — |
| +4 | K192499 | Cyber Blade | SIDAM S.r.l. | 2020 | — |
| +4 | K213597 | MultiCut Solo | Asclepion Laser Technologies GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | Linvatec shaver system Named without a submission number | |
| * | — | Xomed shaver system Named without a submission number | |
| † | K952681 | Stryker Hummer II Microdebrider System | 1995 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K984521 (Richard Wolf Medical Instruments Corp., 1999) has gone furthest, with 9 descendants of its own.
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.
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 Stryker Hummer II MicroDebrider system, is to be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the Head and Neck.
When using the Stryker Hummer II MicroDebrider system, the surgeon has the ability to choose either open or endoscopic viewing and the option to utilize irrigation or vacuum as the surgeon deems necessary. The precise cutting action of the Hummer II Shaver blades allow the surgeon to achieve desired tissue removal, thus minimizing unwanted contour lines, skin discoloration and patient trauma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972584: Stryker Hummer II Microdebrider System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972584
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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