# Wound Retraction And Protection System
> **Product code: PQI** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4371
## Classification
- **FDA Product Code:** PQI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4371
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PQI)
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