# K983224: XPS Drill System

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Oct 21, 1998 after 37 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: 2 generations back to K791407 (1979). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904850: Dual and Single Irr. Systems Models 29550 & 29555, Micro Motors, Inc. (1991) Summary page 2.
- K960853: Ace System, Xomed, Inc. (1996) Summary page 2.

## Indications for use
The XPS Drill System is intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck.

Source page: https://510kreport.com/device/K983224
Methodology: https://510kreport.com/methodology