FDA 510(k)

Solero Microwave Tissue Ablation (MTA) System and Accessories

K-Number: K213067 · 2021-12-03

Decision Date2021-12-03

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 2021-12-03 under approval number K213067. 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 2021-12-03. It is manufactured by AngioDynamics, Inc.. The 510(k) number is K213067.

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 2021-12-03, under approval number K213067.

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.

Related Clinical Trials

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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) PMID: 41517921 Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan. Journal of cardiovascular electrophysiology (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025)

Other Devices by AngioDynamics, Inc.

K162914VenaCure EVLT NeverTouch Procedure Kit K171921VenaCure EVLT NeverTouch Procedure Kit K170775Mini Stick ENVI Non-Vascular Introducer Kit K170695VenaCure EVLT NeverTouch Direct Introducer Sheath K163356Pulse* Spray Infusion System, Uni*Fuse Infusion System K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

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Related Devices (Code: NEY)

K163105Emprint Ablation SystemCovidien, LLC K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.

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.