FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Solero Microwave Tissue Ablation (MTA) System and Accessories
K Number: K221883
·
Decision Mar 7, 2023
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
67
Applicant Total
87
Review Days
251
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Basic Information
- Device Name
- Solero Microwave Tissue Ablation (MTA) System and Accessories
- K Number
- K221883
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AngioDynamics, Inc.
- Date Received
- June 29, 2022
- Decision Date
- March 7, 2023
- Product Code
- NEY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NEY | System, Ablation, Microwave And Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEY), ordered by most recent decision date.
Microwave Ablation Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
FDA 510(k)
FDA Class 2
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swiftPro System (SWF-SPS); Swift System (SWF-SYS)
FDA 510(k)
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Microwave Ablation Generator (KY-2000A, KY-2100A)
FDA 510(k)
FDA Class 2
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Microwave Ablation Antennas
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by AngioDynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885 | Nov 24, 2025 | Substantially Equivalent |
| K253106 | AngioVac Cannula | Oct 24, 2025 | Substantially Equivalent |
| K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | Dec 6, 2024 | Substantially Equivalent |
| K240397 | AlphaVac MMA F1885 System (H787253020) | Apr 1, 2024 | Substantially Equivalent |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | Jul 20, 2023 | Substantially Equivalent |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Mar 27, 2023 | Substantially Equivalent |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Apr 4, 2022 | Substantially Equivalent |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Dec 3, 2021 | Substantially Equivalent |
| K212386 | AngioVac F18 85 | Sep 30, 2021 | Substantially Equivalent |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | Jun 4, 2021 | Substantially Equivalent |