DEN250067
- 510(k) number
- DEN250067
- Device name
- ReneuRx (Neural Ice)
- Applicant
- Brixton Biosciences MA · US
- Product code
- SJA — Injectable For Thermal Treatment Of Musculoskeletal
- Decision date
- 2026-08-21
- Date received
- 2025-12-15
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Orthopedic
Official FDA record: DEN250067
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.