# GEI: Electrosurgical, Cutting & Coagulation & Accessories

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 2,320
- 510(k) review time 2021–2025: median 126 days (middle half 63–226)
- Recalls: 394 (14 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 52
- 2018: 47
- 2019: 48
- 2020: 59
- 2021: 46
- 2022: 55
- 2023: 65
- 2024: 59
- 2025: 52
- 2026: 43

## Most-cited predicates
- K944602: Valleylab Force FX (1995), cited by 22
- K981916: Ligasure Vessel Sealing System (1998), cited by 16
- K945975: Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps (1994), cited by 13
- K984240: Endopath Endoscopic Instruments (1999), cited by 13
- K904993: Laparoscopic Electrosurgical Device (1991), cited by 12
- K070004: Accent (2007), cited by 12
- K984552: Cool-Tip RF System (1999), cited by 12
- K083461: Imagine TC Skin Therapy System (2009), cited by 12
- K013416: Intuitive Surgical Endowrist Endoscopic Instrument Family (2002), cited by 11
- K013639: Thermage Thermacool TC System (2002), cited by 11

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