# EQJ: Bur, Ear, Nose And Throat

- Device class: 1; regulation: 21 CFR 874.4140; FDA's rule: 510(k) exempt
- FDA decisions: 18
- Recalls: 2 (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
- 1980: 1
- 1989: 2
- 1994: 1
- 1995: 8
- 1996: 2
- 1998: 1
- 2004: 1
- 2017: 1

## Most-cited predicates
- K953096: Essential Shaver System (1995), cited by 4
- K953370: Karl Storz Ent Shaver (1995), cited by 1
- K960853: Ace System (1996), cited by 1

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