Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402) +1 more model
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253531 FDA 510(k)
- FDA Product Code
- KGW FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4370 FDA 510(k)
- Regulation Number
- 878.4370 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Alexis Lighted Wound Protector-Retractor is classified as a Ring (Wound Protector), Drape Retention, Internal under FDA regulation 878.4370. This device provides atraumatic, circumferential retraction of surgical wounds while incorporating integrated illumination to enhance visibility of the surgical site. Designed for use in general and plastic surgery, it maintains moisture at the incision and helps reduce superficial surgical site infections. Available in rigid and flexible configurations, it ensures optimal exposure during both laparoscopic and open procedures.
The device is supplied sterile and intended for single-use. The rigid version (CL402) offers maximum exposure with a fixed outer ring, while the flexible version (CL302) conforms to the wound contour. Both variants are non-magnetic and MRI-safe, ensuring compatibility with imaging procedures. Storage requires protection from moisture and physical damage. The device holds an FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device, and is regulated under the General, Plastic Surgery advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Alexis O Wound Protector/Retractor | Applied Medical, Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402 ..., Alexis Protectors and Systems - Applied Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253531 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources Corporation
Sources (1)
- FDA 510(k) K253531 24 fields · synced Sep 20, 2026