510(k) DEN250067
DEN250067 is an FDA 510(k) premarket notification submitted by Brixton Biosciences for the device "ReneuRx (Neural Ice)". The FDA issued a decision of De Novo Granted on Aug 21, 2026. The device falls under product code SJA (Injectable For Thermal Treatment Of Musculoskeletal Pain), a Class II device regulated under 21 CFR 888.3048.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Aug 21, 2026
- Date Received
- Dec 15, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Injectable For Thermal Treatment Of Musculoskeletal Pain
- Device Class
- Class II
- Regulation Number
- 888.3048
- Review Panel
- OR
- Submission Type
An injectable for thermal treatment of musculoskeletal pain is an injectable device intended to inhibit sensory nerve signaling through exchange of thermal energy (e.g., cold temperatures). The device is injected into the extraneural space of the target nerve.