# K965241: Bipolar Suction Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Feb 28, 1997 after 79 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 1.

## Most influential descendants
- K993009: Hydrocision Arthrojet System with Cautery (1999), 1 descendant of its own
- K183199: TRIO Handpiece (2019), 0 descendants of its own
- K031406: Exojet Tissue Management System (2003), 0 descendants of its own

## Indications for use
The Bipolar Suction Coagulator (Angled) is a disposable device, designed to be used in soft tissue surgical procedures that require slow to rapid fluid evacuation and low energy output for the coagulation of the tissue i.e., neurosurgery, endoscopic, sinusoidial, ENT, OB-GYN and plastic surgery.

Source page: https://510kreport.com/device/K965241
Methodology: https://510kreport.com/methodology