# Fem Suite, LLC

- Location (FDA's records): Sonoma, CA
- FDA decisions: 2 (2007–2010): 2 510(k) clearances
- Product codes: HIH (1), HDC (1)
- Predicates its devices cite: 2 (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
- Imagyn Medical, Inc.: 1 (https://510kreport.com/company/imagyn-medical)
- Gyrus Acmi, Inc.: 1 (https://510kreport.com/company/gyrus-acmi)

## Recent decisions
- K093218: Femeye Two (May 18, 2010)
- K062563: Femten Cervical Tenaculum (May 18, 2007)

Source page: https://510kreport.com/company/fem-suite