# K152744: Diego Elite Drill

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jun 10, 2016 after 261 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: 10 generations back to K936109 (1994). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034004: Diego RF Powered Dissector and Drill System Console, Gyrus Ent LLC (2004) Summary page 5.

## Indications for use
The Diego Elite Drill is intended for cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures when used in conjunction with the Diego Elite console. Specific procedures would include Mastoid/Neurotology (Mastoidectomy / Mastoidotomy) and Stapes procedures.

Source page: https://510kreport.com/device/K152744
Methodology: https://510kreport.com/methodology