510(k) K250420

Helios Dura Regeneration Matrix by Helios Biomedical, Inc. — Product Code GXQ

K250420 is an FDA 510(k) premarket notification submitted by Helios Biomedical, Inc. for the device "Helios Dura Regeneration Matrix". The FDA issued a decision of Substantially Equivalent on May 14, 2025. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Helios Biomedical, Inc. has at least 1 other 510(k) clearance on record.