# K963246: Trebay Microdebrider or XPS Straight Shot

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed
- Decided: Sep 23, 1996 after 35 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.
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 no predicate by number.

## Indications for use
This device is intended for the cutting and removal of bone and tissues in ENT, otolaryngology / head and neck surgical procedures.

Source page: https://510kreport.com/device/K963246
Methodology: https://510kreport.com/methodology