# Hart Enterprises, Inc.

- Location (FDA's records): Wyoming, MI
- FDA decisions: 4 (1988–1993): 4 510(k) clearances
- Product codes: DWO (2), BSP (1), GDM (1)
- 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
- K921683: Pencil Point Spinal Needle (Aug 26, 1993)
- K913815: Automated Biopsy Device, Modification (Oct 30, 1991)
- K885149: Needle Insert for Soft Tissue Biopsy Device (Jan 26, 1989)
- K881730: Breast Localization Needles (May 13, 1988)

Source page: https://510kreport.com/company/hart-enterprises