Class Class II

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

K221883 2023-03-07 Special
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Description

Solero Microwave Tissue Ablation (MTA) System and Accessories by AngioDynamics, Inc., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221883
Clearance Date2023-03-07
Clearance TypeSpecial
Product CodeNEY
Regulation Number878.4400

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Predicate lineage for K221883

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Solero Microwave Tissue Ablation (MTA) System and Accessories (K221883) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K213067Solero Microwave Tissue Ablation (MTA) System and AccessoriesAngioDynamics, Inc.2021
K162449Solero MTA System, Solero Microwave Tissue Ablation Applica...AngioDynamics, Inc.2017

Trace the full predicate network for K221883

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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