510(k) K242113
K242113 is an FDA 510(k) premarket notification submitted by Biocircuit Technologies, Inc. for the device "Nerve Wrap (07-DW-001-TAB)". The FDA issued a decision of Substantially Equivalent on April 2, 2025. 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
- April 2, 2025
- Date Received
- July 19, 2024
- 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