Identity
- Trade Name
- EPIONE FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. FDA UDI
- Model / Reference
- 30-0001 v1.0.2 FDA UDI
- Description
- The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760305400031 FDA UDI
- 510(k) Number
- K223758 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Robotic surgical navigation system
Epione by Quantum Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Quantum Surgical
Sources (1)
- FDA UDI 4242fcce-ba19-4d20-bee8-4ac0b5f7f3a5 35 fields · synced Jun 8, 2026