# Gynius AB

- Location (FDA's records): Stockholm, SE
- FDA decisions: 1 (2014–2014): 1 510(k) clearance
- Product codes: HEX (1)
- Predicates its devices cite: 4 (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
- Medgyn Products, Inc.: 2 (https://510kreport.com/company/medgyn-products)
- Intermed Group, Inc.: 1 (https://510kreport.com/company/intermed-group)
- Wallach Surgical Devices, Inc.: 1 (https://510kreport.com/company/wallach-surgical-devices)

## Recent decisions
- K132423: The Gynocular (Apr 8, 2014)

Source page: https://510kreport.com/company/gynius