meddevicedb.com FDA Device Reference

CleanCisionTM Wound Retraction and Protection System

DEN150038 Class II Direct
Decision Date
2016-12-16
Sponsor / Applicant
Prescient Surgical

Technical Specification

510(k) Submission ID DEN150038
Product Code PQI
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4371
Decision Date 2016-12-16
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

CleanCisionTM Wound Retraction and Protection System received FDA 510(k) clearance under submission number DEN150038, sponsored by Prescient Surgical. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2016-12-16.

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.