# K120061: Wound Protector

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: Mar 27, 2012 after 78 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: 1 generation back to K041711 (2004). 1 ancestor in all.
2 later devices descend 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.

## Most influential descendants
- K140064: Surgisleeve Wound Protector (2014), 1 descendant of its own
- K143091: Surgisleeve Wound Protector (2014), 0 descendants of its own

## Indications for use
The 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 atraumnatically-retracted incision.

Source page: https://510kreport.com/device/K120061
Methodology: https://510kreport.com/methodology