# K172132: CleanCision Wound Retraction and Protection System

- Pathway: 510(k) (Traditional)
- Applicant: Prescient Surgical, Inc.
- Decided: Oct 25, 2017 after 103 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
Longest line of descent: 1 generation back to DEN150038 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150038: CleanCisionTM Wound Retraction and Protection System, Prescient Surgical (2016) Summary page 4.

## Indications for use
The CleanCision™ Wound Retraction and Protection System is intended 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/K172132
Methodology: https://510kreport.com/methodology