# K203745: AURORA Evacuator +Coag

- Pathway: 510(k) (Traditional)
- Applicant: Rebound Therapeutics
- Decided: Dec 2, 2021 after 345 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: 2 generations back to K960455 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960455: Bipolar Suction Coagulator, Kirwan Surgical Products, Inc. (1996) Summary page 4.
- K201637: Aurora Evacuator +Coag, Rebound Therapeutics (2020) Summary page 4.

## Most influential descendants
- K230125: Neuroblade System (2023), 0 descendants of its own

## Indications for use
The AURORA Evacuator +Coag is a powered instrument with a handpiece intended for removal of soft tissue and fluids, and coagulation of tissue 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.

Source page: https://510kreport.com/device/K203745
Methodology: https://510kreport.com/methodology