# K896541: Malis Bipolar Electrosurgical System CMC-Iii

- Pathway: 510(k) (Traditional)
- Applicant: Valley Forge Scientific Corp.
- Decided: Jan 29, 1990 after 75 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar (2013), 4 descendants of its own
- K143175: AEx Generator; PlasmaBlade T (2014), 1 descendant of its own
- K211203: Green OR Reprocessed Aquamantys Bipolar Sealer (2022), 0 descendants of its own
- K170381: Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini (2017), 0 descendants of its own
- K170610: PlasmaBlade T (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K896541
Methodology: https://510kreport.com/methodology