Data / Medical devices / France / Quantum Surgical SAS
Quantum Surgical SAS: FDA-registered device maker in montpellier Herault, France, 2 510(k) clearances
Quantum Surgical SAS is registered with the FDA (registration 3023140882) in montpellier Herault, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 3, 2023. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023140882
- Address
- 1000 rue du mas de verchant ZAC Eureka, montpellier Herault, France, 34000
- Owner or operator
- Quantum Surgical SAS (10085404)
- Roles
- Manufacturer
- First device listed
- June 14, 2022
- Registered through
- 2026
- Brand names listed
- EPIONE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Surgery Tray | LRO | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 3, 2023 | K223758 | Epione | JAK | Substantially Equivalent | Quantum Surgical Sas | accessdata.fda.gov |
| February 24, 2022 | K211645 | Epione | JAK | Substantially Equivalent | Quantum Surgical Sas | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 23, 2025 | 96967 | Class II | Ongoing | EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verifica | Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user. | accessdata.fda.gov |
| August 5, 2024 | 95194 | Class II | Completed | The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during | Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust. | accessdata.fda.gov |
Compare with other makers
Updated June 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.