# K161376: DragonFly Surgical Drill System

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Aug 25, 2016 after 99 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: 3 generations back to K002224 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143492: OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece, Bien-Air Surgery SA (2015) Summary page 4.
- K041523: XPS 3000 System, Medtronic Xomed, Inc. (2004) Summary page 4.

## Indications for use
The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

Source page: https://510kreport.com/device/K161376
Methodology: https://510kreport.com/methodology