Solero Microwave Tissue Ablation (MTA) System and Accessories
K-Number: K221883 · 2023-03-07
ApplicantAngioDynamics, Inc.
Decision Date2023-03-07
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Solero Microwave Tissue Ablation (MTA) System and Accessories is a medical device manufactured by AngioDynamics, Inc.. It received FDA 510(k) clearance on 2023-03-07 under approval number K221883. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Solero Microwave Tissue Ablation (MTA) System and Accessories?
Solero Microwave Tissue Ablation (MTA) System and Accessories is a medical device that received FDA 510(k) clearance on 2023-03-07. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K221883.
When was Solero Microwave Tissue Ablation (MTA) System and Accessories approved by the FDA?
Solero Microwave Tissue Ablation (MTA) System and Accessories received FDA 510(k) clearance on 2023-03-07, under approval number K221883.
What company makes Solero Microwave Tissue Ablation (MTA) System and Accessories?
Solero Microwave Tissue Ablation (MTA) System and Accessories is manufactured by AngioDynamics, Inc..
What is the FDA product code for Solero Microwave Tissue Ablation (MTA) System and Accessories?
The FDA product code for Solero Microwave Tissue Ablation (MTA) System and Accessories is NEY.
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Related PubMed Literature
PMID: 42168293
Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling.
Scientific reports (2026)
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K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)
Related Devices (Code: NEY)
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.