Clearance Summary
CleanCision Wound Retraction and Protection System received FDA 510(k) clearance under submission number K172132, sponsored by Prescient Surgical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2017-10-25.
- Submission: K172132
- Applicant / Sponsor: Prescient Surgical, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4371
- Decision date: 2017-10-25
Classification & Regulation
This clearance is catalogued under FDA product code PQI and 21 CFR 878.4371, within the General, Plastic Surgery review panel as a Class II device.