510(k) K172132
K172132 is an FDA 510(k) premarket notification submitted by Prescient Surgical, Inc. for the device "CleanCision Wound Retraction and Protection System". The FDA issued a decision of Substantially Equivalent on Oct 25, 2017. The device falls under product code PQI (Wound Retraction And Protection System), a Class II device regulated under 21 CFR 878.4371. Prescient Surgical, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 25, 2017
- Date Received
- Jul 14, 2017
- Clearance Type
- Traditional
- 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
- 510(k)
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.