Identity
- Trade Name
- Evident FDA UDI
- Generic Name
- Microwave hyperthermia system FDA UDI
- Device Name
- MWA Generator FDA UDI
- Model / Reference
- VTGEN FDA UDI
- Description
- MWA Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884524001579 FDA UDI
- 510(k) Number
- K011676 FDA UDI
- FDA Product Code
- NEY FDA UDI
- GMDN Term
- Microwave hyperthermia 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
Yes
FDA UDI
Category: Microwave hyperthermia system
Evident by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Microwave hyperthermia system.
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- BSD-500 Hyperthermia System — Pyrexar Medical, Inc. · Class III
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
- BSD-2000 Hyperthermia System — Pyrexar Medical, Inc. · Unclassified
- Solero — ANGIODYNAMICS, INC · Class II
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
- HS AMICA — H.S. HOSPITAL SERVICE SPA · Class II
Cleared under the same submission
K011676 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
- Covidien LP
Sources (1)
- FDA UDI fd69aaa7-d660-447f-98b4-251461ecdd5d 36 fields · synced Jun 1, 2026