# K122605: PKS Bill

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 5, 2012 after 100 days
- Product code: HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K936109 (1994). 80 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill), Gyrus Acmi, Inc. (2011) Summary page 1.

## Most influential descendants
- K142525: PK Lap Loop (2014), 0 descendants of its own

## Indications for use
The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.

Source page: https://510kreport.com/device/K122605
Methodology: https://510kreport.com/methodology