# K093296: Alexis Laparoscopic System

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Nov 5, 2009 after 15 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: 1 generation back to K041711 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041711: Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304, Applied Medical Resources Corp. (2004) Summary page 2.

## Indications for use
The Alexis Laparoscopic System 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. * Seal off the incision opening to permit insufflation of the peritoneum. Convert the incision wound to an additional trocar port site. * Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.

Source page: https://510kreport.com/device/K093296
Methodology: https://510kreport.com/methodology