# K990038: Hummer Trak System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Endoscopy
- Decided: Feb 19, 1999 after 44 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: 1 generation back to K952681 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952681: Stryker Hummer II Microdebrider System, Stryker Endoscopy (1995) Summary page 1.
- K972584: Stryker Hummer II Microdebrider System, Stryker Endoscopy (1997) Summary page 1.

## Indications for use
The device is intended to be utilized during Functional Endoscopic Sinus Surgery (FESS) for the excision of soft and osseous tissues in the sinus cavities. The device may be utilized for endoscopic or open plastic, reconstructive, and aesthetic surgery of the head and neck. May be used in conjunction with Visualization Technologies, Inc. (VTI) InstaTrak (K960330) image guided system.

Source page: https://510kreport.com/device/K990038
Methodology: https://510kreport.com/methodology