# K050460: Gyrus Plasmacision and Plasmablend Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Oct 25, 2005 after 244 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: 9 generations back to K936109 (1994). 67 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031082: Everest Bipolar L Hook & PK Bipolar L Hook, Gyrus Medical, Inc. (2003) Summary page 1.
- K041285: Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes), Gyrus Medical, Ltd. (2004) Summary page 1.

## Most influential descendants
- K081766: PKS Omni Instrument (2008), 3 descendants of its own
- K161825: PK AIM (2016), 2 descendants of its own
- K163373: PK AIM (2016), 1 descendant of its own
- K142350: PK J-Hook (2015), 1 descendant of its own
- K213831: Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (2022), 0 descendants of its own

## Indications for use
The Plasmacision and Plasmablend Electrodes are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.

Source page: https://510kreport.com/device/K050460
Methodology: https://510kreport.com/methodology