# K190075: Aurora Evacuator

- Pathway: 510(k) (Special)
- Applicant: Rebound Therapeutics
- Decided: Feb 12, 2019 after 27 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K955168 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180372: Aurora Evacuator, Rebound Therapeutics (2018) Summary page 4.

## Indications for use
The AURORA Evacuator is a powered instrument with a handpiece intended for removal of soft tissue and fluids under direct visualization. Types of direct visualization may include laparoscopic, pelviscopic, endoscopic, percutaneous, and open. Applications include those when access to the surgical site is limited, such as Neurosurgical/Spinal and ENT/Otolaryngological.

Source page: https://510kreport.com/device/K190075
Methodology: https://510kreport.com/methodology