# KNS: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

- Device class: 2; regulation: 21 CFR 876.4300; FDA's rule: 510(k) required
- FDA decisions: 189
- 510(k) review time 2021–2025: median 142 days (middle half 38–239)
- Recalls: 79 (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)
- 2017: 3
- 2018: 5
- 2019: 7
- 2020: 4
- 2021: 4
- 2022: 3
- 2023: 9
- 2024: 3
- 2025: 11
- 2026: 2

## Most-cited predicates
- K013153: Autotome RX Model # 4515, 4516 (2001), cited by 9
- K092309: Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L (2009), cited by 7
- K970278: Microvasive Gold Probe (1997), cited by 7
- K171158: Single Use Electrosurgical knife (2017), cited by 6
- K022595: Wilson-Cook Cystotome (2002), cited by 6
- K033135: Stryker Wireless Universal Footswitch System (2004), cited by 4
- K002583: Tuna (Trans Urethra Needle) Office System (2001), cited by 4
- K183595: Aqua Medical RF Vapor System (2019), cited by 4
- K990628: Gyrus Endourology System (1999), cited by 4
- K030194: Xues-41 Endoscopic Electrosurgical Unit (2003), cited by 4

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