Product code PQI— General, Plastic Surgery
CleanCision Wound Retraction and Protection System
- Classification name
- Wound Retraction And Protection System
- Device class
- Class 2
- Regulation
- 21 CFR 878.4371
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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 context for product code PQI
FDA has cleared devices under product code PQI between 2016 and 2017, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2017
- 2016
Top applicants under product code PQI
Recent clearances under product code PQI
Data sourced from openFDA. This site is unofficial and independent of the FDA.