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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K231691
Device Name Phantom XL Insulated Dilators
Applicant
TeDan Surgical Innovations, Inc.
12320 Cardinal Meadow Dr.
Suite 150
Sugar Land,  TX  77478
Applicant Contact Lynne Davies
Correspondent
TeDan Surgical Innovations, Inc.
12320 Cardinal Meadow Dr.
Suite 150
Sugar Land,  TX  77478
Correspondent Contact Lynne Davies
Regulation Number882.1350
Classification Product Code
GXZ  
Subsequent Product Code
PDQ  
Date Received06/09/2023
Decision Date 06/29/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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