# K231872: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020)

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, LLC
- Decided: Aug 25, 2023 after 60 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 K052203 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052203: Aura 70 Watt Bipolar Electrosurgical Coagulators, Models 28-2000 and 28-2600, Kirwan Surgical Products, Inc. (2005) Summary page 4.

## Indications for use
General-purpose solid-state bipolar generator used to supply High Frequency currents via electrosurgical handpieces for the function of cutting or coagulating soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

Source page: https://510kreport.com/device/K231872
Methodology: https://510kreport.com/methodology