# K041985: XPS Curved Bur

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Aug 12, 2004 after 20 days
- Product code: EQJ (Bur, Ear, Nose And Throat)
- Device class: 1
- Regulation: 21 CFR 874.4140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) ENT Bur: named in the summary without a submission number

## Indications for use
The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 System.

Source page: https://510kreport.com/device/K041985
Methodology: https://510kreport.com/methodology