Cleared Traditional

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 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150924 · Anchor Innovation Medical (A.I.M.) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
112d
Days
Class 2
Risk

K150924 is an FDA 510(k) clearance for the A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Dev.... Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Anchor Innovation Medical (A.I.M.) (Rockville, US). The FDA issued a Cleared decision on July 27, 2015 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.5880 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K150924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date July 27, 2015
Days to Decision 112 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 114d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 138
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