# K041633: Gyrus Plasmacision Laparoscopic Spatula

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Medical, Inc.
- Decided: Oct 22, 2004 after 128 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: 8 generations back to K936109 (1994). 67 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031079: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode, Gyrus Medical, Inc. (2003) Summary page 1.
- K031082: Everest Bipolar L Hook & PK Bipolar L Hook, Gyrus Medical, Inc. (2003) Summary page 1.
- K021777: Gyrus Ent Cogent 2/G2 System (Generator,Accessories Somnoplasty Electrodes and Plasmacision Electrodes), Gyrus Ent LLC (2002) Summary page 1.

## Most influential descendants
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (2011), 3 descendants of its own
- K142289: PK Spatula (2014), 1 descendant of its own
- K122605: PKS Bill (2012), 1 descendant of its own
- K080093: PKS Plasma Morcellator, Models 962000PK, 3620PK (2008), 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 Gyrus PlasmaCision Laparoscopic Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Gyrus PlasmaKinetic Generator or the Gyrus PlasmaKinetic SuperPulse Generator.

Source page: https://510kreport.com/device/K041633
Methodology: https://510kreport.com/methodology