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)
FDA 510(k) clearance K260982 · decided 2026-04-24
Clearance details
- K-number
- K260982
- Device name
- 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
- Decision
- Substantially Equivalent
- Date received
- 2026-03-25
- Decision date
- 2026-04-24
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- KGW
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Rancho Santa, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (K253531) | Applied Medical Resources Corporation | 2026-02-23 |
| ALEXIS O WOUND PROTECTOR/RETRACTOR (K113268) | Applied Medical Resources Corp. | 2013-02-08 |
| ALEXIS ORTHOPAEDIC WOUND RETRACTOR (K100120) | Applied Medical Resources Corp. | 2010-04-02 |
| ALEXIS LAPAROSCOPIC SYSTEM (K093296) | Applied Medical Resources Corp. | 2009-11-05 |
| ALEXIS WOUND RETRACTOR (K062907) | Applied Medical Resources | 2007-01-09 |
| ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 (K041711) | Applied Medical Resources Corp. | 2004-08-26 |
| MICROPOROUS HYPOALLERGENIC (K840946) | Gainor Medical | 1984-08-17 |
| EDGE PROTECTOR, BARRIER (K790306) | Surgikos, Inc. | 1979-02-22 |
Recalls involving this device
No recalls on record reference this clearance.