Cleared Traditional

K171589 - AEON Endoscopic Stapler

K171589 is an FDA 510(k) clearance for AEON Endoscopic Stapler, manufactured by Lexington Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K171589 · Lexington Medical, Inc. · General & Plastic Surgery device
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Nov 2017
Decision
170d
Days
Class 2
Risk

K171589 is an FDA 510(k) clearance for the AEON Endoscopic Stapler. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Lexington Medical, Inc. (Billerica, US). The FDA issued a Cleared decision on November 17, 2017 after a review of 170 days - an extended review cycle.

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 Lexington Medical, Inc. devices

FDA 510(k) Submission Details - K171589

510(k) Number K171589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2017
Decision Date November 17, 2017
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
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 273
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K171589.
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