Cleared Traditional

K110699 - LIGAMAX 5

K110699 is an FDA 510(k) clearance for LIGAMAX 5, manufactured by Ethicon Endo-Sugery, LLC. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K110699 · Ethicon Endo-Sugery, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
11d
Days
Class 2
Risk

K110699 is an FDA 510(k) clearance for the LIGAMAX 5. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Ethicon Endo-Sugery, LLC (Cincinnati, US). The FDA issued a Cleared decision on March 25, 2011 after a review of 11 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ethicon Endo-Sugery, LLC devices

FDA 510(k) Submission Details - K110699

510(k) Number K110699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2011
Decision Date March 25, 2011
Days to Decision 11 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
104d faster than avg
Panel avg: 115d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - FZP Clip, Implantable

All 107
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K110699.
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K093679 · AtriCure, Inc. · Jun 2010
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K091987 · LeMaitre Vascular, Inc. · Apr 2010