# K100816: PK Superpulse Sysem Generator Model 744000

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jul 1, 2010 after 100 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: 4 generations back to K911904 (1991). 15 ancestors in all.
22 later devices descend from it; 3 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031085: Gyrus Plasmakinetic Superpulse System (Generator, Accessories), Gyrus Medical, Inc. (2003) Summary page 2.
- K030194: Xues-41 Endoscopic Electrosurgical Unit, The Olympus Optical Co. (2003) Summary page 2.
- K082054: Gyrus Acmi Plasmakinetic (PK) Superpulse System, Model 744000 and Dual Footswitch Connector Cable, Model 710003, Gyrus Acmi, Inc. (2008) Summary page 2.

## Most influential descendants
- K110268: Forcetriad Electrosurgical Generator (2011), 16 descendants of its own
- K151649: Valleylab FT10 Electrosurgical Platform (2015), 10 descendants of its own
- K170170: Valleylab FT10 Electrosurgical Platform (2017), 8 descendants of its own
- K172757: Valleylab FX8 Electrosurgical Platform (2017), 6 descendants of its own
- K181389: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (2018), 5 descendants of its own

## Indications for use
The Gyrus ACMI PK® Superpulse® System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures. The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K100816
Methodology: https://510kreport.com/methodology