Clearance Summary
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 received FDA 510(k) clearance under submission number K150924, sponsored by Anchor Innovation Medical (A.I.M.). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-07-27.
- Submission: K150924
- Applicant / Sponsor: Anchor Innovation Medical (A.I.M.)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5880
- Decision date: 2015-07-27
Classification & Regulation
This clearance is catalogued under FDA product code GZB and 21 CFR 882.5880, within the Neurology review panel as a Class II device.