Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402) +1 more— 510(k) K253531
Substantially EquivalentApplied Medical Resources Corporation
FDA 510(k) clearance K253531 for Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402) +1 more, Substantially Equivalent on 2026-02-23. Applicant: Applied Medical Resources Corporation. Device class: 2.
Summary
Applied Medical Resources lists two Alexis® Lighted Wound Protector-Retractor versions: Rigid, Medium (CL402) and Flexible, Medium (CL302). They're filed under product code KGW (Ring (Wound Protector), Drape Retention, Internal), and the record doesn't describe them further.
Class II, 21 CFR 878.4370. General, Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).
The record lists the applicant location as Rancho Santa, California. FDA found it substantially equivalent 102 calendar days after receipt (November 13, 2025 to February 23, 2026).
Clearance details
- Device name as filed
- Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
- 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
- Traditional
- Location
- Rancho Santa, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.