Identity
- Trade Name
- SynchroWave Antenna Kit FDA UDI
- Generic Name
- Microwave ablation system probe, non-powered FDA UDI
- Device Name
- 20cm Short Tip Antenna and Cooling Circuit FDA UDI
- Model / Reference
- SWST-1420 FDA UDI
- Description
- 20cm Short Tip Antenna and Cooling Circuit FDA UDI
Identifiers
- Catalog Number
- SWST-1420 FDA UDI
- Primary DI / UDI-DI
- 00851551005095 FDA UDI
- 510(k) Number
- K141785 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave ablation system probe, non-powered 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 20 Centimeter FDA UDI
Category: Microwave ablation system probe, non-powered
SynchroWave Antenna Kit by Perseon Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave ablation system probe, non-powered.
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- TempSure System, Surgical — Cynosure, LLC · Class IIb
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- SURGITRON 4.0 DUAL RF/90 IEC 220-240V — Cynosure, LLC · Class IIb
- Swift® — Emblation , Ltd. · Class I
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
- Microwave Ablation Antennas — Canyon Medical Inc. · Class IIb
Cleared under the same submission
K141785 also covers:
- MicroThermX Microwave Ablation System — ENDOCARE, INC.
- MicroThermX Microwave Ablation System — ENDOCARE, INC.
- SynchroWave Antenna BT Adapter — ENDOCARE, INC.
- SynchroWave Antenna Kit — ENDOCARE, INC.
- SynchroWave Antenna Kit — ENDOCARE, INC.
- SynchroWave Antenna Kit — ENDOCARE, INC.
- SynchroWave Antenna Kit — ENDOCARE, INC.
- SynchroWave Antenna Kit — ENDOCARE, INC.
- SynchroWave Antenna Kit — ENDOCARE, INC.
- MicroThermX Microwave Ablation System — PERSEON CORPORATION
- MicroThermX Microwave Ablation System — PERSEON CORPORATION
- SynchroWave Antenna Kit — PERSEON CORPORATION
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
- Perseon Corporation
Sources (1)
- FDA UDI 582fb698-db23-49b5-ac38-e8a9f5f06081 38 fields · synced May 31, 2026