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QUANTUM SURGICAL SAS

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1927-2025Class IIEPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereoMay 23, 2025
Z-0037-2025Class IIThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in tAugust 5, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K223758EpioneMay 3, 2023
K211645EpioneFebruary 24, 2022