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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.)

510(k) K150924

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150924 Date27 Jul 2015ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZB
Device Class
Class II
Regulation
21 CFR Part 882.5880
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aim Lead Loop Suturing Device is a suturing device used to secure leads and catheters to fascia or ligaments. It consists of a singular anchor threaded with an adjustable loop of non-absorbable size 0 suture. The anchor is composed of carbon fiber reinforced PEEK.

The device is pre-loaded in a needle-tipped, disposable delivery device for tissue insertion. It is supplied in various configurations, including the Aim Lead Loop Suturing Device (1) and Aim Lead Loop Suturing Device (2), with and without the Tension Assist/Suture Cutter Device. The device has been cleared by the FDA under the 510(k) premarket notification process.

Other devices from Anchor Innovation Medical (A.I.M.)

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the A.I.M. Lead Loop Suturing Device used for?

    The A.I.M. Lead Loop Suturing Device is used to secure leads and catheters to fascia or ligaments, providing a reliable and stable connection.

  • How is the device supplied?

    The device is supplied in various configurations, including with and without the Tension Assist/Suture Cutter Device, and is pre-loaded in a needle-tipped, disposable delivery device.

  • Is the device reusable?

    The device is supplied in a disposable delivery device, indicating it is intended for single-use.

  • What materials are used in the device?

    The anchor is composed of carbon fiber reinforced PEEK, and the loop is made of non-absorbable size 0 suture.