# K143091: Surgisleeve Wound Protector

- Pathway: 510(k) (Special)
- Applicant: Covidien, LLC
- Decided: Nov 26, 2014 after 29 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K041711 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140064: Surgisleeve Wound Protector, Covidien (2014) Summary page 4.

## 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 atraumatically retracted incision.

Source page: https://510kreport.com/device/K143091
Methodology: https://510kreport.com/methodology