Solero Microwave Tissue Ablation (MTA) System and Accessories
Summary
AngioDynamics, Inc. received 510(k) clearance for Solero Microwave Tissue Ablation (MTA) System and Accessories, a NEY device. Cleared on 2021-12-03.
Details
Source
510(k) Clearance
External ID
K213067
Action Date
2021-12-03
Status
Special
Category
device
Product Code
NEY
Product Description
Solero Microwave Tissue Ablation (MTA) System and Accessories. Product code: NEY.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 413 device clearances issued this month. AngioDynamics, Inc. has received 9 total clearances in our database.
AngioDynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does AngioDynamics, Inc. have FDA actions?
AngioDynamics, Inc. has 73 FDA actions in our database, including 64 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213067" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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