# K033499: Malis Irrigation Module 1000

- Pathway: 510(k) (Special)
- Applicant: Valley Forge Scientific Corp.
- Decided: Nov 28, 2003 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 K854413 (1985). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854413: Malis Irrigation System, Valley Forge Scientific Corp. (1985) Summary page 1.

## Most influential descendants
- K200169: VFS1 Bipolar Electrosurgical Generator (2020), 0 descendants of its own
- K182801: Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable (2018), 0 descendants of its own

## Indications for use
The MALISTMIrrigation Module 1000 is indicated for use with imgating bipolar forceps with the CODMANB / MALISTMgenerators.

Source page: https://510kreport.com/device/K033499
Methodology: https://510kreport.com/methodology