510(k) K210615

Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) by Thompson Surgical Instruments, Inc. — Product Code GZT

K210615 is an FDA 510(k) premarket notification submitted by Thompson Surgical Instruments, Inc. for the device "Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)". The FDA issued a decision of Substantially Equivalent on May 13, 2022. The device falls under product code GZT (Retractor, Self-Retaining, For Neurosurgery), a Class II device regulated under 21 CFR 882.4800. Thompson Surgical Instruments, Inc. has at least 2 other 510(k) clearances on record.