# Class A Ent.

- Location (FDA's records): Yucca Valley, CA
- FDA decisions: 3 (1992–2002): 3 510(k) clearances
- Product codes: GXZ (2), GXY (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Nicolet Biomedical, Inc.: 1 (https://510kreport.com/company/nicolet-biomedical)

## Its most-cited devices
- K912783: Disposable Monopolar Needle Electrode (1992), cited by 1

## Recent decisions
- K021118: Detachable Monopolar Emg Needle, Models 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 (May 28, 2002)
- K982053: Eeg Electrodes Model 445 Series (Apr 20, 1999)
- K912783: Disposable Monopolar Needle Electrode (Feb 5, 1992)

Source page: https://510kreport.com/company/class-a-ent