Cleared Traditional

Alexis? Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis? Lighted Wound Protector-Retractor, Flexible, Medium (CL302)

K253531 · Applied Medical Resources Corporation · General & Plastic Surgery
Feb 2026
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K253531 is an FDA 510(k) clearance for the Alexis? Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis? Lighted Wound Protector-Retractor, Flexible, Medium (CL302), a Ring (wound Protector), Drape Retention, Internal (Class II — Special Controls, product code KGW), submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on February 23, 2026, 102 days after receiving the submission on November 13, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K253531 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2025
Decision Date February 23, 2026
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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

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