# DWO: Needle, Biopsy, Cardiovascular

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 11
- Recalls: 7 (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)
- 1982: 1
- 1985: 1
- 1987: 2
- 1988: 1
- 1989: 3
- 1991: 1
- 1992: 1
- 1994: 1

## Most-cited predicates
- K890925: Manan Bone Marrow Biopsy Needle (1989), cited by 3
- K853312: Argon Cut Biopsy Needles, Various Sizes (1985), cited by 1
- K921418: Ultra-Core Biopsy Needles (1992), cited by 1
- K933364: Promed Biopsy Needle (1994), cited by 1

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