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510(k) K242841

Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) by Abbott Medical — Product Code GXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2025
Date Received
September 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Radiofrequency Lesion
Device Class
Class II
Regulation Number
882.4725
Review Panel
NE
Submission Type

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