# K230853: EARP Nerve Cuff Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Nvision Biomedical Technologies, Inc.
- Decided: Oct 6, 2023 after 192 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- 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 K923056 (1992). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,, Cadwell Lab, Inc. (2011) Summary page 6.
- K944061: Cueva Cranial Nerve Electrode, Ad-Tech Medical Instrument Corp (1995) Summary page 6.

## Most influential descendants
- K241917: EARP Nerve Cuff Electrode (2024), 0 descendants of its own

## Indications for use
The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.

Source page: https://510kreport.com/device/K230853
Methodology: https://510kreport.com/methodology