Cleared Traditional

K141952 - ECHELON FLEX POWERED VASCULAR STAPLER W...

K141952 is the FDA 510(k) clearance for ECHELON FLEX POWERED VASCULAR STAPLER W... by Ethicon Endo-Surgery, Inc.. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K141952 · Ethicon Endo-Surgery, Inc. · General & Plastic Surgery device
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Nov 2014
Decision
129d
Days
Class 2
Risk

K141952 is an FDA 510(k) clearance for the ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH E.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 24, 2014 after a review of 129 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 Ethicon Endo-Surgery, Inc. devices

Submission Details

510(k) Number K141952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2014
Decision Date November 24, 2014
Days to Decision 129 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 115d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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All 135
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