# K023812: Nessy (Omega) Disposable Split Return Electrodes, Models P/N: 20193-084 and P/N: 20193-085

- Pathway: 510(k) (Special)
- Applicant: Erbe USA, Inc.
- Decided: Nov 29, 2002 after 14 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 K972269 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972269: Disposable Patient Return Electrode, Erbe USA, Inc. (1997) Summary page 1.

## Indications for use
NESSY QTM (Omega) disposable split return electrodes are intended for dispersing and monitoring HF current in electrosurgical interventions.

Source page: https://510kreport.com/device/K023812
Methodology: https://510kreport.com/methodology