# Gallini U.S., LLC

- Location (FDA's records): Richmond, VA
- FDA decisions: 10 (1997–1999): 10 510(k) clearances
- Product codes: KNW (10)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K992499: Gallini Biosystem Bone Marrow Aspiration/Biopsy Needle (Aug 12, 1999)
- K990645: Gallini Atra-Cut Needle (May 19, 1999)
- K990716: Gallini Bycut Needle (May 17, 1999)
- K981301: Speed-Cut Automatic Biopsy System (Jul 8, 1998)
- K980676: Spigal Needle (May 21, 1998)
- K980479: Quick-Cut Automatic Biopsy System (May 6, 1998)
- K980248: Acri R Needle (Feb 18, 1998)
- K974440: IBI (Jan 30, 1998)

Source page: https://510kreport.com/company/gallini-us