# 3D-Shaper Medical S.L

- Location (FDA's records): Barcelona, ES
- FDA decisions: 2 (2022–2025): 2 510(k) clearances
- Product codes: KGI (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 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
- Hologic, Inc.: 1 (https://510kreport.com/company/hologic)
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC: 1 (https://510kreport.com/company/ge-medical-systems-ultrasound-primary-care-diagnostics)

## Its most-cited devices
- K220822: 3D-Shaper (2022), cited by 1

## Recent decisions
- K251022: 3D-Shaper (Sep 5, 2025)
- K220822: 3D-Shaper (Dec 9, 2022)

Source page: https://510kreport.com/company/3d-shaper-medical-s-l