# K972584: Stryker Hummer II Microdebrider System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Oct 1, 1997 after 83 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Linvatec shaver system: named in the summary without a submission number
- (no number) Xomed shaver system: named in the summary without a submission number

## Most influential descendants
- K984521: Riwo Drive System 2302 with Generator, Small Motor Handles, 8563.111, 8563.351 (1999), 9 descendants of its own
- K030082: Power Control 2303 with Power Stick M4, Model# 2303.011/.901/.911, 8564.121/.851 (2003), 8 descendants of its own
- K041610: Morce Scope Set 8970 with Power Control 2303 and Suction Pump 2207 (2004), 6 descendants of its own
- K192499: Cyber Blade (2020), 2 descendants of its own
- K213597: MultiCut Solo (2023), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K972584
Methodology: https://510kreport.com/methodology