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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 K253907
Device Name Disposable Radiofrequency Cannula
Applicant
ABBOTT MEDICAL
6901 Preston Rd.
Plano,  TX  75024
Applicant Contact Katee Perez Anderson
Correspondent
ABBOTT MEDICAL
6901 Preston Rd.
Plano,  TX  75024
Correspondent Contact Katee Perez Anderson
Regulation Number882.4725
Classification Product Code
GXI  
Date Received12/05/2025
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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