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PREVENA 125 and PREVENA PLUS 125 Therapy Units

DEN180013 Class II Direct
Decision Date
2019-04-19
Sponsor / Applicant
Kci USA, Inc.

Technical Specification

510(k) Submission ID DEN180013
Product Code QFC
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4783
Decision Date 2019-04-19
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

PREVENA 125 and PREVENA PLUS 125 Therapy Units received FDA 510(k) clearance under submission number DEN180013, sponsored by Kci USA, Inc.. 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 2019-04-19.

Classification & Regulation

This clearance is catalogued under FDA product code QFC and 21 CFR 878.4783, within the General, Plastic Surgery review panel as a Class II device.