510(k) K241917

EARP Nerve Cuff Electrode by Retropsoas Technologies, LLC — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2024
Date Received
July 1, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type