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.
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
- 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.