# EFQ: Gauze/Sponge, Internal

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 271
- Recalls: 5 (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)
- 1990: 1
- 1991: 4
- 1992: 3
- 1993: 2
- 1994: 49
- 1995: 16
- 1996: 16
- 1997: 10
- 1998: 6
- 1999: 6

## Most-cited predicates
- K821150: NU-Gauze Sponge (1982), cited by 2
- K830264: Floret Tonsil & Adenoid Sponges (1983), cited by 1
- K820106: X-Ray Guaze Sponges (1982), cited by 1
- K895086: Gauze Sponge (1989), cited by 1
- K942070: Lorrex Cover Sponges STERILE2'S and Non-Sterile (1994), cited by 1
- K812736: Softcare Barrier Wet Dressing (1981), cited by 1
- K922055: Sterile and Non-Sterile Gauze Sponges (1992), cited by 1

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