510(k) K172644

Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base by Stimwave Technologies Incorporated — Product Code GZB

K172644 is an FDA 510(k) premarket notification submitted by Stimwave Technologies Incorporated for the device "Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base". The FDA issued a decision of Substantially Equivalent on November 3, 2017. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Stimwave Technologies Incorporated has at least 7 other 510(k) clearances on record.