# KNF: Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

- Device class: 2; regulation: 21 CFR 884.4160; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 30 days (middle half 23–99)
- Recalls: 4 (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)
- 2013: 1
- 2014: 1
- 2018: 1
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K070315: Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 (2007), cited by 5
- K964441: Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic Resection and Ablation (Opera)] [Specialized Tissu (1997), cited by 2
- K932456: Jarit Surgical Instruments (1994), cited by 2
- K971146: Laparette (1997), cited by 1
- K971621: Resistick Solid Laparoscopic Electrodes (1997), cited by 1
- K211535: Sonata Transcervical Fibroid Ablation System 2.2 (2021), cited by 1
- K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) (2023), cited by 1
- K010752: Aesculap's Modular Endoscopic Instruments for Gynecology (2001), cited by 1
- K173703: Sonata Sonography-Guided Transcervical Fibroid Ablation System (2018), cited by 1
- K240503: Sonata Transcervical Fibroid Ablation System 2.2 (2024), cited by 1

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