510(k) K210665
K210665 is an FDA 510(k) premarket notification submitted by Biocircuit Technologies, Incorporated for the device "Nerve Tape". The FDA issued a decision of Substantially Equivalent on July 15, 2022. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2022
- Date Received
- March 5, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Nerve
- Device Class
- Class II
- Regulation Number
- 882.5275
- Review Panel
- NE
- Submission Type