# HIN: Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

- Device class: 2; regulation: 21 CFR 884.4150; FDA's rule: 510(k) required
- FDA decisions: 16
- Recalls: 0 (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)
- 1979: 1
- 1987: 1
- 1991: 1
- 1994: 2
- 1998: 1
- 1999: 1
- 2011: 2
- 2012: 2
- 2013: 2
- 2014: 1

## Most-cited predicates
- K111059: Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) (2011), cited by 3
- K971565: Bicoag Coagulating Forceps (1998), cited by 2
- K943776: Coagulator Cutter, Endoscopic Bipolar and Accessories (1994), cited by 1
- K122605: PKS Bill (2012), cited by 1
- K111751: Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop Electrode, Versapoint II Footswitch, Vers (2011), cited by 1

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