510(k) clearance

ReneuRx™ (Neural Ice)

FDA 510(k) source

510(k) number

DEN250067

Applicant

Brixton Biosciences

Decision date

Aug 21, 2026

Date received

Dec 15, 2025

Decision

Unknown

Clearance type

Direct

Product code

SJA

Device type

Injectable For Thermal Treatment Of Musculoskeletal Pain

Device class

Class II

Regulation

21 CFR 888.3048

Advisory committee

Orthopedic

Third party

N

Location

Cambridge, MA, US