510(k) K212982

Medispine - Spinal Needle, Glospine - Spinal Needle by Global Medikit Limited — Product Code BSP

K212982 is an FDA 510(k) premarket notification submitted by Global Medikit Limited for the device "Medispine - Spinal Needle, Glospine - Spinal Needle". The FDA issued a decision of Substantially Equivalent on July 29, 2022. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Global Medikit Limited has at least 1 other 510(k) clearance on record.