# K201637: Aurora Evacuator +Coag

- Pathway: 510(k) (Traditional)
- Applicant: Rebound Therapeutics
- Decided: Aug 12, 2020 after 57 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: 1 generation back to K960455 (1996). 1 ancestor in all.
2 later devices descend 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.

## Most influential descendants
- K203745: AURORA Evacuator +Coag (2021), 1 descendant of its own
- 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.

Source page: https://510kreport.com/device/K201637
Methodology: https://510kreport.com/methodology