# K960455: Bipolar Suction Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Kirwan Surgical Products, Inc.
- Decided: Feb 27, 1996 after 28 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.
9 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K965241: Bipolar Suction Coagulator (1997), 3 descendants of its own
- K201637: Aurora Evacuator +Coag (2020), 2 descendants of its own
- K203745: AURORA Evacuator +Coag (2021), 1 descendant of its own
- K150993: NICO TRIOwand (2015), 1 descendant of its own
- K993009: Hydrocision Arthrojet System with Cautery (1999), 1 descendant of its own

Source page: https://510kreport.com/device/K960455
Methodology: https://510kreport.com/methodology