# Cultiv8 1, LLC

- Location (FDA's records): Plymouth, MN
- FDA decisions: 1 (2026–2026): 1 510(k) clearance
- Product codes: DYB (1)
- Predicates its devices cite: 1 (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

## Firms whose devices it cites most
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)

## Recent decisions
- K253652: Genie MAX Large Bore Introducer Sheath (Jan 22, 2026)

Source page: https://510kreport.com/company/cultiv8-1