# K052203: Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Oct 20, 2005 after 69 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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) 28-1000, Kirwan 50 Watt Bipolar Generator: named in the summary without a submission number
- (no number) 26-2500, Aura, 20 Watt Bipolar Electrosurgical Coagulator: named in the summary without a submission number
- (no number) RF111, Pegasys Electrosurgical Generator: named in the summary without a submission number
- (no number) 80-1170, Malis TM Bipolar Electrosurgical System CMC-Ill: named in the summary without a submission number

## Most influential descendants
- K231872: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) (2023), 0 descendants of its own
- K061544: Stellartech 100 Coagulation System (2006), 0 descendants of its own

## Indications for use
General purpose solid state bipolar generator to supply RF signal to electrosurgical hand-pieces used on soft body tissue where a wide range of tissue types, patient conditions and load impedances are encountered. Where applicable (i.e., Auraplus, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.

Source page: https://510kreport.com/device/K052203
Methodology: https://510kreport.com/methodology