510(k) K233533
K233533 is an FDA 510(k) premarket notification submitted by Biocircuit Technologies, Inc. for the device "NerveTape". The FDA issued a decision of Substantially Equivalent on February 12, 2024. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Biocircuit Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2024
- Date Received
- November 2, 2023
- 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