K253531 is an FDA 510(k) clearance for the Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402). This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.4370.
| 510(k) Number | K253531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | KGW — Ring (wound Protector), Drape Retention, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |