# HGI: Electrocautery, Gynecologic (And Accessories)

- Device class: 2; regulation: 21 CFR 884.4120; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 206 days (middle half 206–206)
- Recalls: 20 (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)
- 1999: 2
- 2000: 2
- 2001: 2
- 2002: 1
- 2006: 1
- 2007: 1
- 2012: 1
- 2014: 1
- 2016: 1
- 2021: 1

## Most-cited predicates
- K921884: FORCE 2 (1992), cited by 3
- K130606: Fmwand Ferromagnetic Surgical System (2014), cited by 2
- K931338: 16 Electrodes (Blade, Ball, Needle & Loop) (1994), cited by 1
- K152843: Liger Medical HTU-110 (2016), cited by 1
- K061651: Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158 (2006), cited by 1
- K905263: Utah Essu (1991), cited by 1
- K942986: Electrodes (Blade, Ball, Needle, and Loop) (1995), cited by 1
- K121881: Domain Surgical System (2012), cited by 1
- K955093: Aspiration/Coagulation Electrode Ace-311 & Ace-511 (1996), cited by 1
- K952483: Leep System 1000 (1995), cited by 1

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