# K062907: Alexis Wound Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Jan 9, 2007 after 104 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) OBI Mobius: named in the summary without a submission number

## Most influential descendants
- K100120: Alexis Orthopaedic Wound Retractor (2010), 0 descendants of its own

## Indications for use
The Alexis Wound Retractor (large and extra large size only) is indicated for use to provide abdominal access during routine non-urgent cesarean deliveries. The Alexis Wound Retractor was previously cleared for the following general indications for use (K041711): • Access the abdominal cavity during surgery through an atraumatically retracted incision. • Delivery 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 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/K062907
Methodology: https://510kreport.com/methodology