Identity
- Trade Name
- SynchroWave Antenna BT Adapter FDA UDI
- Generic Name
- Microwave ablation system generator FDA UDI
- Device Name
- SynchroWave Antenna BT Adapter Package FDA UDI
- Model / Reference
- SWBT-AB FDA UDI
- Description
- SynchroWave Antenna BT Adapter Package FDA UDI
Identifiers
- Catalog Number
- SWBT-AB FDA UDI
- Primary DI / UDI-DI
- 00810563020601 FDA UDI
- 510(k) Number
- K141785 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave ablation system generator 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: Microwave ablation system generator
SynchroWave Antenna BT Adapter by Endocare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave ablation system generator.
- Emprint — Covidien LP · Class II
- MicroThermX Microwave Ablation System — PERSEON CORPORATION · Class II
- NEUWAVE — NeuWave Medical, Inc. · Class I
- HYGEA — Hygea Medical Technology Co., Ltd. · Class II
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Mima-Pro — Mima-Pro (Nan Tong) Scientific Inc. · Class II
- NEUWAVE — NeuWave Medical, Inc. · Class I
- MicroThermX Microwave Ablation System — Varian Medical Systems, Inc · Class II
Cleared under the same submission
K141785 also covers:
- MicroThermX Microwave Ablation System — ENDOCARE, INC.
- MicroThermX Microwave Ablation System — 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
- 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
- Endocare, Inc.
Sources (1)
- FDA UDI b618c355-2c84-4f7d-8cef-a77af52832a3 37 fields · synced Jun 1, 2026