# K023482: Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Jan 15, 2003 after 90 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 26-1500, Kirwan 20 Watt Bipolar Micro Coagulator: named in the summary without a submission number
- (no number) 28-1000, Kirwan 50 Watt Bipolar Generator: named in the summary without a submission number

## Indications for use
The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

Source page: https://510kreport.com/device/K023482
Methodology: https://510kreport.com/methodology