# DWZ: Device, Biopsy, Endomyocardial

- Device class: 2; regulation: 21 CFR 870.4075; FDA's rule: 510(k) required
- FDA decisions: 23
- 510(k) review time 2021–2025: median 33 days (middle half 33–33)
- Recalls: 1 (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)
- 1993: 1
- 1994: 1
- 1995: 1
- 1997: 2
- 1999: 1
- 2000: 1
- 2001: 1
- 2007: 1
- 2017: 1
- 2025: 1

## Most-cited predicates
- K882383: Maggi Series Ultra. Needle, Biopsy/Catheter Guides (1988), cited by 4
- K974175: Heartport Endoaortic Clamp Catheter (1997), cited by 3
- K914567: Cordis Bipal Biopsy Forceps (1991), cited by 1
- K870186: Endomyocardial Biopsy Device (1987), cited by 1
- K881412: Myocard Biopsy Forcep (1988), cited by 1
- K973818: T-Rex Biopsy Forceps (1997), cited by 1
- K170726: Biopsy Forceps (2017), cited by 1

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