# GAA: Needle, Aspiration And Injection, Disposable

- Device class: 1; regulation: 21 CFR 878.4800; FDA's rule: 510(k) exempt
- FDA decisions: 107
- 510(k) review time 2021–2025: median 113 days (middle half 113–113)
- Recalls: 25 (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)
- 1991: 4
- 1992: 3
- 1993: 4
- 1994: 3
- 1996: 2
- 1998: 2
- 2000: 1
- 2001: 1
- 2011: 1
- 2023: 1

## Most-cited predicates
- K851957: Chiba Needle (1985), cited by 3
- K863848: Manan Brest Tumor Localization Needle (1986), cited by 2
- K940024: Manan General Purpose Introducer Needle (1994), cited by 2
- K994151: Percutx-Injection/Aspiration Needle Probes/Devices (2000), cited by 2
- K962425: Bonopty Coaxial Bone Biopsy System with Eccentric Drill (10-1072,3,4) (1996), cited by 2
- K940025: Manan Bone Marrow Harvest Needles (1994), cited by 2
- K851953: Hawkin Needle (1985), cited by 1
- K854238: Needle W/Stylet for Implantation (1985), cited by 1
- K760775: Terumo Disposable Spinal Needle (1976), cited by 1
- K915417: Kopan's Target (1992), cited by 1

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