# K031079: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode

- 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.
35 later devices descend from it; 3 cite it directly.
0 of 37 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
- K081129: Enseal Powertip,Nseal-514D,-525D,-535D,-545D,-514RD,-525RD,-535RD,-545RD, Etrio-314D,-325D,-335D,-345D, Enseal Universal (2008), 24 descendants of its own
- K111202: Surgical Tissue Management System (2012), 11 descendants of its own
- K101990: Ethicon Endo-Surgery Generator G11, Model GEN11 (2011), 11 descendants of its own
- K141122: Harmonic Scallop Blade, Generator G11 (2014), 9 descendants of its own
- K132703: Thunderbeat (2014), 9 descendants of its own

## Indications for use
Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.

Source page: https://510kreport.com/device/K031079
Methodology: https://510kreport.com/methodology