510(k) K241825

Microwave Ablation Antennas by Canyon Medical, Inc. — Product Code NEY

K241825 is an FDA 510(k) premarket notification submitted by Canyon Medical, Inc. for the device "Microwave Ablation Antennas". The FDA issued a decision of Substantially Equivalent on September 20, 2024. The device falls under product code NEY (System, Ablation, Microwave And Accessories), a Class II device regulated under 21 CFR 878.4400. Canyon Medical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
June 24, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type