# K963884: Somnus Disposable Multiple Electrode Coagulating Probe Model 350

- Pathway: 510(k) (Traditional)
- Applicant: Somnus Medical Technologies, Inc.
- Decided: Dec 16, 1996 after 81 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.
2 later devices descend from it; 2 cite 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K970838: Somnus Model 30XX Disposable Tri-Needle Coagulating Electrode (1998), 0 descendants of its own
- K970837: Somnus Model 6000 Disposable Tissue Coagulating Electrode (1998), 0 descendants of its own

## Indications for use
The Somnus™ Model 3000 Disposable Tri-Needle Coagulating Electrode is intended for use in the coagulation of tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K963884
Methodology: https://510kreport.com/methodology