510(k) K241917
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