# DEN150038: CleanCisionTM Wound Retraction and Protection System

- Pathway: De Novo (Direct)
- Applicant: Prescient Surgical
- Decided: Dec 16, 2016 after 491 days
- Product code: PQI (Wound Retraction And Protection System)
- Device class: 2
- Regulation: 21 CFR 878.4371
- 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. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K172132: CleanCision Wound Retraction and Protection System (2017), 0 descendants of its own

## Indications for use
Indicated for use by a surgeon during abdominal surgery to retract the surgical incision, provide access to the abdominal cavity, and irrigate the surgical wound edge. The device may aid in the prevention of wound edge contamination. This device is intended to deliver a sterile irrigant solution and serve as a conduit for fluid removal from the surgical wound edge.

Source page: https://510kreport.com/device/DEN150038
Methodology: https://510kreport.com/methodology