# K140064: Surgisleeve Wound Protector

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Mar 12, 2014 after 61 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: 2 generations back to K041711 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 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 1.
- K120061: Wound Protector, Covidien, Formerly US Surgical A Divison of Tyco H (2012) Summary page 1.

## Most influential descendants
- K143091: Surgisleeve Wound Protector (2014), 0 descendants of its own

## Indications for use
The Surgisleeve™ Wound Protector 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, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumnatically retracted incision.

Source page: https://510kreport.com/device/K140064
Methodology: https://510kreport.com/methodology