510(k) K252995

Durashield Device Kit by SurGenTec, LLC — Product Code GZT

K252995 is an FDA 510(k) premarket notification submitted by SurGenTec, LLC for the device "Durashield Device Kit". The FDA issued a decision of Substantially Equivalent on September 17, 2026. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. SurGenTec, LLC has at least 10 other 510(k) clearances on record.