# K260982: 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)

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Resources Corporation
- Decided: Apr 24, 2026 after 30 days
- Product code: KGW (Ring (Wound Protector), Drape Retention, Internal)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K840372 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253531: Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302), Applied Medical Resources Corporation (2026) Summary page 6.

## Indications for use
The Alexis lighted wound protector-retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size. In addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery. The small and medium Alexis lighted wound protector-retractors are capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site. In addition, indicated sizes may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.

Source page: https://510kreport.com/device/K260982
Methodology: https://510kreport.com/methodology