Quantum Surgical Sas

Medical device manufacturer in montpellier, Fran.

2510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K223758EpioneJAK · Traditional 05/03/2023SE
K211645EpioneJAK · Traditional 02/24/2022SE

Recalls

RecallProductInitiated
Z-1927-2025 Class IIEPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled…Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined… 05/23/2025Open, Classified
Z-0037-2025 Class IIThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to…Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product… 08/05/2024Completed