Cleared Special

Solero Microwave Tissue Ablation (MTA) System and Accessories

K221883 · AngioDynamics, Inc. · General & Plastic Surgery
Mar 2023
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K221883 is an FDA 510(k) clearance for the Solero Microwave Tissue Ablation (MTA) System and Accessories, a System, Ablation, Microwave And Accessories (Class II — Special Controls, product code NEY), submitted by AngioDynamics, Inc. (Marlborough, US). The FDA issued a Cleared decision on March 7, 2023, 251 days after receiving the submission on June 29, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number K221883 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NEY — System, Ablation, Microwave And Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4400

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