# KGE: Forceps, Biopsy, Electric

- Device class: 2; regulation: 21 CFR 876.4300; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 220 days (middle half 189–242)
- 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)
- 2014: 1
- 2016: 3
- 2017: 2
- 2018: 3
- 2019: 1
- 2021: 2
- 2022: 1
- 2023: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K062517: Electrosurgical Hemostatic Forceps Series (2006), cited by 6
- K101657: Radial 4 Hot Biopsy Forceps Box 5; Radial Jaw 4 Hot Biopsy Forceps Box 20; Radial Jaw 4 Hot Biopsy Forceps Box 40 (2010), cited by 3
- K955052: Olympus FD-1/2-1 Hot Biopsy Forceps (1996), cited by 2
- K160625: Disposable Hot Biopsy Forceps (2016), cited by 2
- K923470: Disposable Hot Biopsy Forceps (1993), cited by 2
- K932266: Symbiosis Dispos Gastro Biopsy Forceps W/Reuse Han (1994), cited by 2
- K090583: Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 (2009), cited by 2
- K953355: Gip/Meid-Globe Hot Biopsy Forceps (1996), cited by 1
- K171096: Fujifilm Diathermic Slitter (FlushKnife) (2017), cited by 1
- K905088: Hot Biopsy Forceps (1991), cited by 1

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