ReneuRx (Neural Ice)— 510(k) DEN250067
UnknownBrixton Biosciences
FDA 510(k) clearance DEN250067 for ReneuRx (Neural Ice), Unknown on 2026-08-21. Applicant: Brixton Biosciences. Device class: 2.
Summary
Brixton Biosciences filed ReneuRx (Neural Ice) under product code SJA, injectables for thermal treatment of musculoskeletal pain. The record doesn't describe the product beyond its name and that code.
Class II, 21 CFR 888.3048. Orthopedic is both the classification panel and the review panel. The record lists the submission type as Direct.
Brixton filed from Cambridge, Massachusetts. The decision date came 249 calendar days after the received date (December 15, 2025 to August 21, 2026).
Clearance details
- Applicant
- Brixton Biosciences
- Product code
- Product code SJA
- Device class
- Class 2
- Regulation
- 21 CFR 888.3048
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Cambridge, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.