# K113268: Alexis O Wound Protector/Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Feb 8, 2013 after 462 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 K954824 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031889: Alexis Wound Retractor, Applied Medical Resources Corp. (2003) Summary page 1.

## Indications for use
The Applied Wound Protector/Retractor is indicated for use to: * Access the abdominal cavity during surgery through an atraumnatically retracted incision. * Deliver maximum exposure of the abdominal cavity with minimum incision size. * Protect against wound contamination during laparoscopic and open surgery.

Source page: https://510kreport.com/device/K113268
Methodology: https://510kreport.com/methodology