Cleared Special

K221883 - Solero Microwave Tissue Ablation (MTA) System and Accessories (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K221883 · AngioDynamics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
251d
Days
Class 2
Risk

K221883 is an FDA 510(k) clearance for the Solero Microwave Tissue Ablation (MTA) System and Accessories. Classified as System, Ablation, Microwave And Accessories (product code NEY), Class II - Special Controls.

Submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on March 7, 2023 after a review of 251 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all AngioDynamics, Inc. devices

Submission Details

510(k) Number K221883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2022
Decision Date March 07, 2023
Days to Decision 251 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 114d · This submission: 251d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NEY System, Ablation, Microwave And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - NEY System, Ablation, Microwave And Accessories

All 67
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K221883.
Microwave Ablation Device
K252632 · Nanjing Dewen Medical Technology Co., Ltd. · Mar 2026
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)
K253771 · Nanjing Devin Medical Technology Co., Ltd. · Mar 2026
swiftPro System (SWF-SPS)
K250718 · Emblation Limited · Aug 2025
Microwave Ablation Generator (KY-2000A, KY-2100A)
K241827 · Canyon Medical, Inc. · Sep 2024
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K241825 · Canyon Medical, Inc. · Sep 2024
IntelliBlate Microwave Ablation System Console (IB-CON)
K240480 · Varian Medical Systems, Inc. · Jul 2024