K260982

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)

510(k) number: K260982
Device name: 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 CA · US
Product code: KGW — Ring (Wound Protector), Drape Retention, Internal
Decision date: 2026-04-24
Date received: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General, Plastic Surgery

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K260982.pdf

Official FDA record: K260982

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.