PQI — Wound Retraction And Protection System Class II
FDA product code PQI covers "Wound Retraction And Protection System", a Class II medical device regulated under 21 CFR 878.4371. Submissions are reviewed by the General, Plastic Surgery panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PQI
- Device Class
- Class II
- Regulation Number
- 878.4371
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.