510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN250067Unknown

ReneuRx™ (Neural Ice)

Brixton Biosciences, Cambridge MA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250067 is the FDA 510(k) clearance record for ReneuRx™ (Neural Ice), a class II device, cleared for Brixton Biosciences on under FDA product code SJA (Injectable For Thermal Treatment Of Musculoskeletal Pain). FDA's definition for product code SJA reads: "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...". As of , FDA records show no recalls naming DEN250067.

Clearance record

Decision date
Received
(249 days to decision)
Product code
SJA Injectable For Thermal Treatment Of Musculoskeletal Pain
Regulation
21 CFR 888.3048
Device class
Class II
Review panel
Orthopedic
Applicant
Brixton Biosciences 1000 Massachusetts Ave., Cambridge MA
Third party review
No

Clearances, product code SJA

Trailing 12 months
1 clearance under product code SJA in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SJA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260