Identity
- Trade Name
- US Medical Innovations FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- Canady Helios Cold Plasma Ablation System FDA UDI
- Model / Reference
- XL-1000CP FDA UDI
- Description
- Canady Helios Cold Plasma Ablation System FDA UDI
Identifiers
- Catalog Number
- XL-1000CP FDA UDI
- Primary DI / UDI-DI
- B413XL1000CP0 FDA UDI
- 510(k) Number
- K240297 FDA UDI
- FDA Product Code
- OAB FDA UDIGEI FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Category: Electrosurgical system
US Medical Innovations by Us Medical Innovations, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K240297 also covers:
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
- Us Medical Innovations, Llc
Sources (1)
- FDA UDI c79a26e6-475d-4fe0-9278-405f8de3c3c5 35 fields · synced Jun 6, 2026