# FAS: Electrode, Electrosurgical, Active, Urological

- Device class: 2; regulation: 21 CFR 876.4300; FDA's rule: 510(k) required
- FDA decisions: 58
- 510(k) review time 2021–2025: median 139 days (middle half 116–155)
- Recalls: 7 (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)
- 2010: 3
- 2011: 1
- 2012: 2
- 2015: 1
- 2016: 1
- 2017: 2
- 2021: 2
- 2022: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- K955531: Arthrocare Bipolar Loop Electrode System (1996), cited by 7
- K961069: Arthrocare Urologic Multi-Electrode Electrosurgery System (1996), cited by 5
- K973820: Usa Elite System Vaportrode Vaporization Electrode and Vaportome Resection Electrode (1998), cited by 5
- K100275: Working Element, Resection Button Electrode for Plasma Vaporizaton, HF-Resection Electrode Loops and Bands (2010), cited by 4
- K953983: Evap-Electrodes Types 8423, 8427, 8410 & 8413 Electrosurgical Vaporization of Soft Tissue (1996), cited by 2
- K971512: Ams Coaguloop Resection Electrode (1997), cited by 2
- K171965: Resection Electrodes with HF cable (2017), cited by 2
- K152092: Resection Electrodes (2015), cited by 2
- K120418: Electrosugrical Resection and Vaporization Electrode Series (2012), cited by 2
- K102781: Resection Button Electrode for Plasma Vaporization, HF-Resection Electrode Rollers and Needles, Loops and Bands (2011), cited by 2

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