# K031082: Everest Bipolar L Hook & PK Bipolar L Hook

- Pathway: 510(k) (Special)
- Applicant: Gyrus Medical, Inc.
- Decided: May 21, 2003 after 47 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: 1 generation back to K904993 (1991). 1 ancestor in all.
15 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904993: Laparoscopic Electrosurgical Device, Everest Medical Corp. (1991) Summary page 1.

## Most influential descendants
- K041633: Gyrus Plasmacision Laparoscopic Spatula (2004), 8 descendants of its own
- K050460: Gyrus Plasmacision and Plasmablend Electrodes (2005), 6 descendants of its own
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (2011), 3 descendants of its own
- K081766: PKS Omni Instrument (2008), 3 descendants of its own
- K161825: PK AIM (2016), 2 descendants of its own

## Indications for use
Electrosurgical coagulation, electrosurgical cutting, dissection of tissue, irrigation and aspiration during the performance of laparoscopic and general surgical procedures.

Source page: https://510kreport.com/device/K031082
Methodology: https://510kreport.com/methodology