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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K242841
Device Name Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
Applicant
ABBOTT MEDICAL
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact Elijah Canal
Correspondent
ABBOTT MEDICAL
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact Elijah Canal
Regulation Number882.4725
Classification Product Code
GXI  
Date Received09/19/2024
Decision Date 05/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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