Cleared Traditional

K143129 - easyEndo Linear Cutting Stapler and Loa...

Also marketed or referenced as:
Loading Unit)

K143129 is an FDA 510(k) clearance for easyEndo Linear Cutting Stapler and Loa..., manufactured by Ezisurg Medical Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K143129 · Ezisurg Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Jan 2015
Decision
90d
Days
Class 2
Risk

K143129 is an FDA 510(k) clearance for the easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ezisurg Medical Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 29, 2015 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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.

View all Ezisurg Medical Co., Ltd. devices

FDA 510(k) Submission Details - K143129

510(k) Number K143129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2014
Decision Date January 29, 2015
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 162
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K143129.
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ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
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ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING
K140560 · Ethicon Endo-Surgery, LLC · Apr 2014
RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS
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