# GDM: Needle, Aspiration And Injection, Reusable

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 48
- 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)
- 1987: 3
- 1988: 9
- 1989: 6
- 1990: 7
- 1992: 2
- 1993: 1
- 1994: 1
- 1995: 2
- 1997: 1
- 2007: 1

## Most-cited predicates
- K953064: Bioaccess Marrow Harvest System (1995), cited by 2
- K882240: Storz Univ Irrigat/Aspira & Phacoemulsifcation Pac (1988), cited by 2
- K882601: E-Z-EM (R) Lufkin Biopsy Needles (1988), cited by 2
- K904667: NA Needles (1990), cited by 2
- K071732: Marrowminer (2007), cited by 1
- K843830: J -Jamshidi Type-Bone Marrow Biopsy/Aspi (1984), cited by 1
- K830235: Franzen Needle Guide (1983), cited by 1
- K902177: Manan Bone Biopsy Needle (1990), cited by 1

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