Cleared Special

K221883 - Solero Microwave Tissue Ablation (MTA) System and Accessories

K221883 is an FDA 510(k) clearance for Solero Microwave Tissue Ablation (MTA) ..., manufactured by AngioDynamics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEY cleared through the Special 510(k) pathway after a 251-day FDA review.

K221883 · AngioDynamics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K221883

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
136d slower than avg
Panel avg: 115d · This submission: 251d
Pathway characteristics
Modification to existing cleared device.

NEY Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (NEY) and FDA review panel - the closest regulatory comparables to K221883.
AB1 Electrosurgical Instrument, Creo Electrosurgical System
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K222388 · Emblation , Ltd. · May 2023
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K223272 · Mima-Pro Scientific, Inc. · Feb 2023
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K221672 · Creo Medical, Ltd. · Feb 2023
NEUWAVE Microwave Ablation System and Accessories
K220472 · Neuwave Medical, Inc. · Aug 2022
K221883 · Solero Microwave Tissue Ablation (MTA) System and Accessories
Download PDF FDA Summary AngioDynamics, Inc.