510(k) K241917

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

K241917 is an FDA 510(k) premarket notification submitted by Retropsoas Technologies, LLC for the device "EARP Nerve Cuff Electrode". The FDA issued a decision of Substantially Equivalent on July 31, 2024. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Retropsoas Technologies, LLC has at least 1 other 510(k) clearance on record.

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