K253531

Substantially Equivalent

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

Applicant: Applied Medical Resources Corporation
Product code: KGW
Advisory panel: General, Plastic Surgery
Date received: 2025-11-13
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Santa, CA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.