DeviceClearance

Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)— 510(k) K162449

Substantially Equivalent

AngioDynamics, Inc.

FDA 510(k) clearance K162449 for Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm), Substantially Equivalent on 2017-05-05. Applicant: AngioDynamics, Inc.. Device class: 2.

Clearance details

Applicant
AngioDynamics, Inc.
Product code
Code NEY
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marlborough, MA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code NEY

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More clearances from AngioDynamics, Inc.

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Adverse events under product code NEY

product code NEY
Death
24
Injury
388
Malfunction
462
Other
1
Total
875

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K162449

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162449.

Data sourced from openFDA. This site is unofficial and independent of the FDA.