Epione
FDA 510(k) clearance K223758 · decided 2023-05-03
Clearance details
- K-number
- K223758
- Device name
- Epione
- Applicant
- Quantum Surgical Sas
- Decision
- Substantially Equivalent
- Date received
- 2022-12-15
- Decision date
- 2023-05-03
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Montpellier, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, s recall (Z-1927-2025) | QUANTUM SURGICAL SAS | 2025-06-09 |
| The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to a recall (Z-0037-2025) | QUANTUM SURGICAL SAS | 2024-10-09 |