Alexis lighted wound protector-retractor, flexible, extra small (cl312) +6 more— 510(k) K260982
Substantially EquivalentApplied Medical Resources Corporation
FDA 510(k) clearance K260982 for Alexis lighted wound protector-retractor, flexible, extra small (cl312) +6 more, Substantially Equivalent on 2026-04-24. Applicant: Applied Medical Resources Corporation. Device class: 2.
Clearance details
- Device name as filed
- Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)
- 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
- Special
- Location
- Rancho Santa, CA, US
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