510(k) K253531 · KGW Ring (Wound Protector), Drape Retention, Internal
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
| Applicant | Applied Medical Resources Corporation, Rancho Santa CA, US |
| Decision | Substantially Equivalent, Feb 23, 2026 |
| Received | Nov 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253531
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.