# K081766: PKS Omni Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus-Acmi L.P.
- Decided: Aug 8, 2008 after 49 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K936109 (1994). 87 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023493: PK Zip Wing Cutting Dissector, Gyrus Medical, Inc. (2002) Summary page 1.
- K024286: Gyrus Open Forceps, Gyrus Medical, Inc. (2003) Summary page 1.
- K061975: Plasmaseal Open Forceps, Models 2103PK and 91701PK, Acmi Corporation (2006) Summary page 1.
- K050460: Gyrus Plasmacision and Plasmablend Electrodes, Gyrus Medical, Inc. (2005) Summary page 1.
- K031011: Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500, Valleylab, Inc. (2003) Summary page 1.
- K050550: Gyrus General Purpose Electrosurgical Generator, Gyrus Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K161825: PK AIM (2016), 2 descendants of its own
- K163373: PK AIM (2016), 1 descendant of its own
- K170908: PK AIM (2017), 0 descendants of its own

## Recalls of this device
- Jun 9, 2021 · Class II · Z-2380-2021: Expired adhesive used as an electrical insulation barrier and as a secondary retention bond failed and could result in foreign body / biologic reaction within the patient and / or electrical continuit

## Indications for use
The Gyms ACMI Inc. PKS Omni Instrument is intended for electrosurgical coagulation, mechanical grasping, and dissection of tissue, and sealing of vessels up to 3mm, during the performance of laparoscopic and general (open) surgical procedures when used in conjunction with the Gyms ACMI G400 workstation.

Source page: https://510kreport.com/device/K081766
Methodology: https://510kreport.com/methodology