510(k) K150924

A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device by Anchor Innovation Medical (A.I.M.) — Product Code GZB

K150924 is an FDA 510(k) premarket notification submitted by Anchor Innovation Medical (A.I.M.) for the device "A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device". The FDA issued a decision of Substantially Equivalent on July 27, 2015. The device falls under product code GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief)), a Class II device regulated under 21 CFR 882.5880. Anchor Innovation Medical (A.I.M.) has at least 1 other 510(k) clearance on record.