510(k) DEN150038
DEN150038 is an FDA 510(k) premarket notification submitted by Prescient Surgical for the device "CleanCisionTM Wound Retraction and Protection System". The FDA issued a decision of De Novo Granted on December 16, 2016. The device falls under product code PQI (Wound Retraction And Protection System), a Class II device regulated under 21 CFR 878.4371. Prescient Surgical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 16, 2016
- Date Received
- August 13, 2015
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Retraction And Protection System
- Device Class
- Class II
- Regulation Number
- 878.4371
- Review Panel
- SU
- Submission Type
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.