# JOS: Electrode, Electrosurgical

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 36
- Recalls: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 4
- 1996: 3
- 1997: 2
- 1998: 1
- 1999: 1
- 2000: 2
- 2001: 2
- 2002: 1
- 2005: 1
- 2016: 1

## Most-cited predicates
- K903302: Electrode, Electrosurgery (1990), cited by 4
- K881763: Colorado Needle Electrode (1988), cited by 3
- K993885: Ultrablator Electrode (2000), cited by 3
- K944992: Electrodes (1995), cited by 2
- K050923: Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction Ablator (2005), cited by 2
- K792365: Bipolar Forceps (1979), cited by 1
- K973554: Valley Forge Bipolar Ball Tip Electrode (1997), cited by 1
- K974735: Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade & Needle; Standard 45 Degree Blade (1998), cited by 1
- K962313: Modified Leveen Needle Electrode (1996), cited by 1
- K895331: Electrosurgical Electrode (1989), cited by 1

Source page: https://510kreport.com/product-code/JOS
Data by year (CSV): https://510kreport.com/product-code/JOS.csv