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The Tracker / August 2026 / DEN250067

510(k) cleared

ReneuRx (Neural Ice)

Brixton Biosciences · Aug 21, 2026 · DEN250067 · In the directory

FDA cleared the ReneuRx (Neural Ice) from Brixton Biosciences on Aug 21, 2026 under DEN250067, a direct 510(k). The device falls under product code SJA, Injectable For Thermal Treatment Of Musculoskeletal Pain, regulated at 21 CFR 888.3048 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Dec 15, 2025. The decision came 249 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Brixton Biosciences in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250067?

DEN250067 is the FDA 510(k) for ReneuRx (Neural Ice), submitted by Brixton Biosciences. FDA's decision date was Aug 21, 2026, under product code SJA (Injectable For Thermal Treatment Of Musculoskeletal Pain).

Who makes the ReneuRx (Neural Ice)?

Brixton Biosciences, based in Cambridge, MA, is the applicant of record for DEN250067. The company is listed in the MedDevice Startups directory.

How long did the DEN250067 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Aug 21, 2026, 249 days later.

← All decisions in August 2026

Sources

In the startup directory

Brixton Biosciences

Orthopedics & Spine · Cambridge, MA