# K203494: Nissha Medical Technologies Neutral Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Nissha Medical Technologies, Ltd.
- Decided: Feb 23, 2021 after 88 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: 6 generations back to K853291 (1985). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173877: BOWA Neutral Electrodes, Bowa-Electronics GmbH & Co. KG (2018) Summary page 4.

## Most influential descendants
- K242204: Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) (2024), 0 descendants of its own

## Indications for use
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient’s skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A2s in a 60 s period occur. Nissha Medical Technologies Neutral Electrodes – Boston Scientific: Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient’s skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products. The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices “Boston Scientific G4™ and 1A/1B Radiofrequency Generators”.

Source page: https://510kreport.com/device/K203494
Methodology: https://510kreport.com/methodology