# K960569: Disposable Patient Return Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Erbe USA, Inc.
- Decided: Mar 11, 1996 after 34 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The ERBE Disposable Patient Return Electrodes are a key accessory in the efficacious application of HF surgical instruments and are intended to be used primarily with Erbe's ranpe of Electrosurgical Generators but they are also compatible with generators from other manufacturers.

Source page: https://510kreport.com/device/K960569
Methodology: https://510kreport.com/methodology