# K011381: Hummer IV Microdebrider System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Instruments
- Decided: May 25, 2001 after 18 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K080052: Stryker Essx with Navigation Mount (2008), 0 descendants of its own
- K073633: Stryker Essx Microdebrider System (2008), 0 descendants of its own

## Recalls of this device
- Mar 18, 2014 · Class II · Z-1247-2014: Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or

Source page: https://510kreport.com/device/K011381
Methodology: https://510kreport.com/methodology