Cleared Traditional

K113268 - ALEXIS O WOUND PROTECTOR/RETRACTOR

K113268 is an FDA 510(k) clearance for ALEXIS O WOUND PROTECTOR/RETRACTOR, manufactured by Applied Medical Resources Corp.. The device is a Class 2 General & Plastic Surgery device with product code KGW cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K113268 · Applied Medical Resources Corp. · General & Plastic Surgery device
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Feb 2013
Decision
462d
Days
Class 2
Risk

K113268 is an FDA 510(k) clearance for the ALEXIS O WOUND PROTECTOR/RETRACTOR. Classified as Ring (wound Protector), Drape Retention, Internal (product code KGW), Class II - Special Controls.

Submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on February 8, 2013 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4370 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Applied Medical Resources Corp. devices

FDA 510(k) Submission Details - K113268

510(k) Number K113268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2011
Decision Date February 08, 2013
Days to Decision 462 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
347d slower than avg
Panel avg: 115d · This submission: 462d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KGW Device Classification - Class 2, Special Controls

Product Code KGW Ring (wound Protector), Drape Retention, Internal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KGW Ring (wound Protector), Drape Retention, Internal

All 7
Devices cleared under the same product code (KGW) and FDA review panel - the closest regulatory comparables to K113268.
Alexis lighted wound protector-retractor, flexible, extra small (cl312)
K260982 · Applied Medical Resources Corporation · Apr 2026
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)
K253531 · Applied Medical Resources Corporation · Feb 2026
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
K100120 · Applied Medical Resources Corp. · Apr 2010
ALEXIS LAPAROSCOPIC SYSTEM
K093296 · Applied Medical Resources Corp. · Nov 2009
ALEXIS WOUND RETRACTOR
K062907 · Applied Medical Resources · Jan 2007
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
K041711 · Applied Medical Resources Corp. · Aug 2004