# K031889: Alexis Wound Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Sep 22, 2003 after 96 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- 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: 1 generation back to K954824 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954824: Protector Retractor & Protector Retractor with Drape, Medical Creative Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K041131: Apple Medical OB Mobius Elastic Retractor (2004), 1 descendant of its own
- K113268: Alexis O Wound Protector/Retractor (2013), 0 descendants of its own
- K050256: Apple Medical/OB Mobius Elastic Retractor (2005), 0 descendants of its own

## Indications for use
The Applied Alexis Wound Retractor is indicated for use to: Access the abdominal cavity during surgery through an atraumatically retracted incision. Deliver maximum exposure of the abdominal cavity with minimum incision size. Protect against wound contamination during laparoscopic and open surgery. The smaller two sizes of Alexis are also intended to be used to: Seal off the incision opening to permit insufflating the peritoneum. Convert the incision wound to an additional trocar port site.

Source page: https://510kreport.com/device/K031889
Methodology: https://510kreport.com/methodology