Wound Retraction And Protection System
The Wound Retraction and Protection System is a prescription surgical device used by surgeons to retract the surgical incision, provide access to the surgical wound, protect and irrigate the wound, and serve as a conduit for removing fluid from the wound during open surgery. It is classified as FDA Class 2 under 21 CFR 878.4371 in the General and Plastic Surgery specialty, requiring 510(k) clearance. The device is eligible for third-party 510(k) review. Product code PQI; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQI
- Device Class
- FDA class 2
- Regulation Number
- 878.4371
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.