# K050364: Malis 2000 Bipolar Electrosurgical System

- Pathway: 510(k) (Special)
- Applicant: Valley Forge Scientific Corp.
- Decided: Mar 9, 2005 after 23 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 K955346 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955346: VFS - 300 Bipolar Electrosurgery System, Valley Forge Scientific Corp. (1995) Summary page 1.

## Most influential descendants
- K200169: VFS1 Bipolar Electrosurgical Generator (2020), 0 descendants of its own

## Indications for use
The MALLS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.

Source page: https://510kreport.com/device/K050364
Methodology: https://510kreport.com/methodology