Cleared Special

K260982 - Alexis lighted wound protector-retractor, flexible, extra small (cl312) (FDA 510(k) Clearance)

Also includes:
Alexis lighted wound protector-retractor, flexible, small (cl301) Alexis lighted wound protector-retractor, flexible, medium (cl302) Alexis lighted wound protector-retractor, flexible, large (cl303) Alexis lighted wound protector-retractor, rigid, small (cl401) Alexis lighted wound protector-retractor, rigid, medium (cl402) Alexis lighted wound protector-retractor, rigid, large (cl403)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K260982 · Applied Medical Resources Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
30d
Days
Class 2
Risk

K260982 is an FDA 510(k) clearance for the Alexis lighted wound protector-retractor, flexible, extra small (cl312). Classified as Ring (wound Protector), Drape Retention, Internal (product code KGW), Class II - Special Controls.

Submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on April 24, 2026 after a review of 30 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Applied Medical Resources Corporation devices

Submission Details

510(k) Number K260982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2026
Decision Date April 24, 2026
Days to Decision 30 days
Submission Type Special
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
84d faster than avg
Panel avg: 114d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.