# K041711: Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Aug 26, 2004 after 64 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
No predicates in its family tree.
9 later devices descend from it; 6 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Heartport Soft Tissue Retractor: named in the summary without a submission number

## Most influential descendants
- K120061: Wound Protector (2012), 2 descendants of its own
- K253531: Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (2026), 1 descendant of its own
- K140064: Surgisleeve Wound Protector (2014), 1 descendant of its own
- K113496: Virture Male Sling System with Alexis Wound Retractor Convenience Kit (2012), 1 descendant of its own
- 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) (2026), 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. * 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/K041711
Methodology: https://510kreport.com/methodology