# K031078: Everest Bipolar Macro, Micro & Molly Forceps & Gyrus Bipolar Macro, Micro & Molly Forceps

- Pathway: 510(k) (Special)
- Applicant: Gyrus Medical, Inc.
- Decided: May 16, 2003 after 42 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 7 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
- K190909: ArtiSential Bipolar Fenestrated Forceps (2020), 4 descendants of its own
- K200875: ArtiSential Laparoscopic Instruments - Electrodes (2020), 3 descendants of its own
- K220384: ArtiSential Laparoscopic Instruments-Electrodes (2022), 1 descendant of its own
- K252666: Articulator Arthroscopic Bur (2025), 0 descendants of its own
- K230499: ArtiSential Laparoscopic Instruments-Electrodes (2023), 0 descendants of its own

## Recalls of this device
- Aug 27, 2014 · Class II · Z-0100-2015: Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the produ

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

Source page: https://510kreport.com/device/K031078
Methodology: https://510kreport.com/methodology