DeviceClearance

Alexis lighted wound protector-retractor, flexible, extra small (cl312) +6 more— 510(k) K260982

Substantially Equivalent

Applied Medical Resources Corporation

FDA 510(k) clearance K260982 for Alexis lighted wound protector-retractor, flexible, extra small (cl312) +6 more, Substantially Equivalent on 2026-04-24. Applicant: Applied Medical Resources Corporation. Device class: 2.

Summary

Applied Medical Resources' record names seven versions of the Alexis lighted wound protector-retractor: flexible in extra small, small, medium, and large (cl312, cl301, cl302, cl303), and rigid in small, medium, and large (cl401, cl402, cl403). All are filed under product code KGW (Ring (Wound Protector), Drape Retention, Internal).

Class II, 21 CFR 878.4370. It came in as a Special 510(k), and General and Plastic Surgery is both the classification panel and the review panel.

Applied Medical Resources filed from Rancho Santa, California. Review took 30 calendar days (March 25 to April 24, 2026).

Clearance details

Device name as filed
Alexis lighted wound protector-retractor, flexible, extra small (cl312);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)
Applicant
Applied Medical Resources Corporation
Product code
Product code KGW
Device class
Class 2
Regulation
21 CFR 878.4370
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rancho Santa, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.