# K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Sep 1, 2011 after 136 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: 10 generations back to K936109 (1994). 79 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070315: Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8, Lina Medical Aps (2007) Summary page 1.
- K041633: Gyrus Plasmacision Laparoscopic Spatula, Gyrus Medical, Inc. (2004) Summary page 1.
- K050550: Gyrus General Purpose Electrosurgical Generator, Gyrus Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K122605: PKS Bill (2012), 1 descendant of its own
- K142525: PK Lap Loop (2014), 0 descendants of its own
- K130305: Lina Bipolar Loop; Standard Size, Large Size, Extra Large Size (2013), 0 descendants of its own

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

Source page: https://510kreport.com/device/K111059
Methodology: https://510kreport.com/methodology